FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ENDOSCOPIC MULTIFEED STAPLER
MDR report key: 149217
·
Received February 13, 1998
Report
- Report Number
- 1527736-1998-00368
- Event Type
- Malfunction
- Date Received
- February 13, 1998
- Report Date
- January 16, 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 #.48867. EES #.980508/J. ENDOPATH ENDOSCOPIC MULTIFEED STAPLER: BASED UPON INQUIRY INFORMATION RECEIVED, VISUAL EXAMINATION AND FUNCTIONAL TEST IT WAS CONCLUDED THAT THE REPORTED EVENT OCCURRED DUE TO A YIELDED NOSE. NO CONCLUSION COULD BE REACHED IF THE TWISTED STAPLES CAUSED THE NOSE WELD TO YIELD OR IF THE YIELDED NOSE WELD CAUSED TO THE STAPLE TO BECOME TWISTED IN THE NOSE.
Description of Event or Problem · 1
IT WAS REPORTED THE EMS WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED BY THE AFFILIATE THE CLIPS 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 | KURE3G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |