FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ENDOSCOPIC MULTIFEED STAPLER
MDR report key: 153460
·
Received February 25, 1998
Report
- Report Number
- 1527736-1998-00527
- Event Type
- Malfunction
- Date Received
- February 25, 1998
- Report Date
- January 28, 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
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
TRACKING #.49241. EES #.980801/J. D6: DEVICE RETURNED WITH NO LOT IDENTIFICATION. 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 A PARTIALLY YIELDED CARTRIDGE NOSE WELD AND TO THREE STAPLES JAMMED IN THE NOSE. NO CONCLUSION COULD BE REACHED IF THE YIELDED NOSE WELD CAUSED THE STAPLES TO BECOME JAMMED IN THE NOSE OR IF THE STAPLES JAMMED IN THE NOSE CAUSED THE NOSE WELD TO YIELD.
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 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |