MalfunctionReceived 2026-06-30SIGNIA · COVIDIEN SURGICAL
ACCORDING TO THE CLINICAL STUDY, INTRA-OPERATIVELY, THE STAPLER DID NOT FIRE. THE ANASTOMOSIS WAS COMPLETED MANUALLY TO RESOLVE THE ISSUE. THERE WERE NO CLINICAL STUDY ASSESSMENTS PERFORMED.
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 195,000+ 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.
195,226
Total reports in MAUDE
154,607
Malfunctions
38,432
Injuries
1,369
Deaths
Live from openFDA · dataset last updated 2026-07-14
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
1,040
reports mentioning “failed to fire”
Often entangled with loading, positioning, or tissue-thickness selection
Difficult to remove
982
reports mentioning “difficult to remove”
Post-fire release problems often involve technique interaction
Misfire
846
reports mentioning “misfire”
Frequently involves firing sequence or reload handling
Inadvertent action
497
reports mentioning “inadvertently”
Marker for unintended activation or release — action-stage errors
Labeled 'user error'
178
reports mentioning “user error”
How reporters themselves attribute the event
Wrong size
24
reports mentioning “wrong size”
Cartridge/tissue mismatch is a classic perception-stage use error
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.
MalfunctionReceived 2026-06-30UNKNOWN ENDO GIA SULU · COVIDIEN SURGICAL
ACCORDING TO THE CLINICAL STUDY, INTRA-OPERATIVELY, THE STAPLER DID NOT FIRE. THE ANASTOMOSIS WAS COMPLETED MANUALLY TO RESOLVE THE ISSUE. THERE WERE NO CLINICAL STUDY ASSESSMENTS PERFORMED.
MalfunctionReceived 2026-06-30ABSORBATACK · COVIDIEN SURGICAL
IT WAS REPORTED THAT A TACKER APPEARED TO BE DAMAGED DURING SURGERY AND WAS REPLACED WITH ANOTHER TACKER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
MalfunctionReceived 2026-06-30ENDO GIA · COVIDIEN
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE JAMMED WHILE FIRING AND WAS UNABLE TO COMPLETE THE CUT. ADDITIONALLY, THE STAPLER WAS LOCKED ON TISSUE, AND WHEN IT WAS WITHDRAWN, THE TISSUE TORE ALONG THE CUT LINE. POOR STAPLE FORMATION AND BLEEDING WERE NOTED. SURGICAL TIME WAS EXTENDED DUE TO THE DEVICE ISSUE. A DIFFERENT RELOAD WAS USED TO RESOLVE THE ISSUE.
MalfunctionReceived 2026-06-30ENDO GIA · COVIDIEN
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY, FIRING COULD BE PERFORMED PARTWAY THROUGH BUT THEN STOPPED. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
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.
Limitations — read before drawing conclusions
- MAUDE has no denominator. Report counts can't be turned into rates — procedure volumes aren't in the data, so more reports ≠ more dangerous.
- Reporting is biased and incomplete. Underreporting is well documented; media attention, litigation, and policy changes (see the ASR story above) all move the curve.
- Keyword matching is a heuristic. Phrase counts surface candidates for human reading. A validated use-error classification needs trained reviewers and a coding scheme (e.g., PCA taxonomy) with reliability checks.
- Duplicates and follow-ups exist. The same event can generate multiple MDRs; no deduplication is attempted here.
- Narratives are secondhand. Most are written by manufacturers from user communications, with their own framing incentives.