MAUDE Signal Explorer

Surgical Staplers · A Human Factors Lens

An independent demo by Kennedy DeSousa

Post-market surveillance, read like a human factors engineer

What 198,000+ adverse-event reports say about surgical staplers

HFE teams mostly look forward — formative studies, validation, design controls. But the FDA's MAUDE database is a backward-looking goldmine: real use errors, in real ORs, in the reporters' own words. This page mines the public openFDA device-event API for surgical staplers (product codes GAG & GDW) and shows how post-market signals can seed formative-study hypotheses.

197,585

Total reports in MAUDE

156,659

Malfunctions

38,718

Injuries

1,378

Deaths

Live from openFDA · dataset last updated 2026-09-08

Reports per year — and the hidden-database story

For years, stapler manufacturers could route adverse events through FDA's “Alternative Summary Reporting” program — tens of thousands of malfunction reports that never appeared in public MAUDE. After investigative reporting surfaced the practice, FDA ended ASR in mid-2019 and the hidden reports flooded into the public record. The lesson for anyone reading this data: the shape of a reporting curve reflects policy as much as risk.

A use-error lens on the narratives

Event narratives often encode perception, cognition, or action failures — the raw material of use-related risk analysis. These phrase counts are a deliberately simple heuristic for surfacing candidate reports to read, not a validated classifier:

Failed to fire

1,047

reports mentioning “failed to fire”

Boundary case

Often entangled with loading, positioning, or tissue-thickness selection — but a jammed mechanism with perfect technique is a device failure. Run the perfect-device test before claiming it.

Difficult to remove

996

reports mentioning “difficult to remove”

Action

Post-fire release problems often involve technique interaction with the release design

Misfire

853

reports mentioning “misfire”

Action

Frequently involves firing sequence or reload handling — execution of a known procedure

Inadvertent action

499

reports mentioning “inadvertently”

Action

Marker for unintended activation or release — classic slip during execution

Labeled 'user error'

178

reports mentioning “user error”

Reporter-attributed

How reporters themselves attribute the event — attribution, not analysis; treat as a pointer, not a classification

Wrong size

24

reports mentioning “wrong size”

Perception

Cartridge/tissue mismatch — the user didn't detect or judge the tissue thickness the design asked them to assess

Which analysis owns this cause?

A signal only becomes a use-relatedrisk when the initiating event is a human perceiving, deciding, or acting while the device performs to specification. Device deviates from spec → that's a failure mode for the FMEA family. Two tests sort every narrative:

1 · The perfect-device test

Would this scenario still occur with a flawlessly functioning device? Yes → use-related analysis. No— it requires a malfunction → failure-mode analysis. A “failed to fire” narrative can land either way, which is why it's tagged a boundary case above.

2 · The initiating-event test

When a chain involves both a failure and a user, ask what starts it. The failure itself belongs to the failure-mode analyses — but the user-response task the failure creates (respond, recover, replace) is use-related risk in its own right.

The latest reports, in the reporters' own words

The most recent stapler narratives in MAUDE, with use-error phrases highlighted. Reading raw narratives is where the method earns its keep — counts point you somewhere; the words tell you why.

InjuryReceived 2026-08-31GIA · Covidien

According to the reporter, on (b)(6) 2026, post-operative of a right colectomy under coelio performed on (b)(6) 2026, the patient had an emergency CT (computed tomography) scan due to abdominal pain, rectorrhagia, and hyperthermia. The patient had anterior anastomotic release with localized peritonitis possibly due to anastomotic bleeding. The patient underwent re-operation on (b)(6) 2026 to resolve the issue. The patient was put on antibiotics. The patient was discharged on (b)(6) 2026.

InjuryReceived 2026-08-31SureForm · INTUITIVE SURGICAL, INC

It was reported that during a da Vinci-assisted pulmonary lobectomy surgical procedure, the White SureForm 45 Reload staple line bled after a misfire; the staple line was incomplete. The site reported being required to manually select the Reload color from the Surgeon Side Console before the fire. The SureForm 45 Curved-Tip Stapler was replaced with a backup stapler. After a successful firing sequence, no error messages were observed; the White staple line bled and required intervention. The surgeon reports the level of bleeding produced from the staple line was unexpected; the estimated blood loss was not provided. The bleeding was controlled intraoperatively; the procedure was completed robotically with a backup reload.

MalfunctionReceived 2026-08-31N/A · Ethicon Endo-Surgery, LLC.

It was reported that, during an unknown surgery, the first firing was completed without issue. However, during the second firing, the firing knob did not move. Another device was used to complete the case. There were no adverse consequences to the patient. No further information is available.

MalfunctionReceived 2026-08-31N/A · Ethicon Endo-Surgery, LLC.

It was reported that during an unknown surgery ,the device could not be fired. Another device was used to complete the case. There were no adverse consequences to the patient. No further information is available.

MalfunctionReceived 2026-08-31N/A · Ethicon Endo-Surgery, LLC.

It was reported that during an Unknown surgery, after fired, noted the staples malformed. Used suture to oversew. There was no patient consequence reported. No additional information can be provided.

Why this matters for HFE teams

1 · Signal

Trend breaks and phrase clusters point to where users struggle — before your own study budget is spent.

2 · Hypothesis

Each recurring narrative pattern (“wrong size,” “failed to fire”) becomes a candidate use error for task analysis and PCA classification.

3 · Study design

Formative scenarios and IFU probes get grounded in documented field failures instead of conference-room guesses.

4 · Risk file

Confirmed patterns flow into the use-related risk analysis — recalibrating severity and likelihood on existing rows, seeding new ones, and tracing each use-error chain to the hazards the top-level risk file owns.

Limitations — read before drawing conclusions