FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ENDOSCOPIC MULTIFEED STAPLER
MDR report key: 306416
·
Received November 27, 2000
Report
- Report Number
- 1527736-2000-06005
- Event Type
- Malfunction
- Date Received
- November 27, 2000
- Date of Event
- November 1, 2000
- Report Date
- November 1, 2000
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GAG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT (1) EMS WAS USED DURING A LAPAROSCOPIC BURCH PROCEDURE. IT WAS REPORTED BY THE REP THAT THE SURGEON WAS STAPLING MESH TO COOPER'S LIGAMENT AND STAPLES WERE NOT FORMING CORRECTLY. SOME FIRED CORRECTLY BUT VERY INCONSISTENTLY. OPENED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ENDOSCOPIC MULTIFEED STAPLER | STAPLERS - ENDOSCOPIC | GAG | ETHICON ENDO-SURGERY, INC. | NA | N4JL3A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |