FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ENDOSCOPIC MULTIFEED STAPLER
MDR report key: 148453
·
Received February 9, 1998
Report
- Report Number
- 1527736-1998-00312
- Event Type
- Malfunction
- Date Received
- February 9, 1998
- Report Date
- January 12, 1998
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GAG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TRACKING #.48872. EES #.980513/J. ENDOPATH ENDOSCOPIC MULTIFEED STAPLER: BASED UPON THE INQUIRY INFORMATION RECEIVED, VISUAL EXAMINATION AND FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE REPORTED EVENT DURING SURGERY OCCURRED DUE TO THREE MISALIGNED STAPLES IN THE TRACK. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE MISALIGNMENT. NO CONCLUSION COULD BE REACHED AS TO HOW THE STAPLES HAD BECOME MISALIGNED IN THE TRACK.
Description of Event or Problem · 1
IT WAS REPORTED THE EMS WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THE STAPLES WOULD NOT DELIVER. THERE WAS NO CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ENDOSCOPIC MULTIFEED STAPLER | ENDOSCOPIC STAPLER | GAG | ETHICON ENDO-SURGERY, INC. | NA | K467P78 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |