FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ENDOSCOPIC MULTIFEED STAPLER
MDR report key: 341716
·
Received July 11, 2001
Report
- Report Number
- 1527736-2001-03664
- Event Type
- Malfunction
- Date Received
- July 11, 2001
- Report Date
- June 20, 2001
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GAG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT (1) EMS WAS USED DURING A HERNIA REPAIR PROCEDURE. IT WAS REPORTED BY THE REP THAT THE HOSPITAL CLAIMS DEVICE WAS FIRED AND STAPLES DID NOT FORM PROPERLY. THE DEVICE DID NOT FIRE RIGHT. OPENED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31160 | ENDOPATH ENDOSCOPIC MULTIFEED STAPLER | STAPLERS - ENDOSCOPIC | GAG | ETHICON ENDO-SURGERY, INC. | NA | P4L393 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |