FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ENDOSCOPIC MULTIFEED STAPLER
MDR report key: 218895
·
Received April 12, 1999
Report
- Report Number
- 1527736-1999-02076
- Event Type
- Malfunction
- Date Received
- April 12, 1999
- Date of Event
- March 18, 1999
- Report Date
- March 19, 1999
- Manufacturer
- ETHICON ENDO-SURGERY, INC. S.A. DE C.V.
- Product Code
- GAG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED BY THE REP THAT THE SURGEON USED THE EMS STAPLER TO AFFIX THE MESH TO THE INGUINAL REGION. THE 1ST EMS JAMMED AFTER ABOUT (4) FIRINGS. THEY THEN OPENED ANOTHER EMS WHICH ALSO JAMMED AFTER 4-5 FIRINGS. THEY THEN OPENED ANOTHER EMS TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ENDOSCOPIC MULTIFEED STAPLER | STAPLERS - ENDOSCOPIC | GAG | ETHICON ENDO-SURGERY, INC. S.A. DE C.V. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |