FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ENDOSCOPIC MULTIFEED STAPLER
MDR report key: 253491
·
Received December 8, 1999
Report
- Report Number
- 1527736-1999-06274
- Event Type
- Malfunction
- Date Received
- December 8, 1999
- Date of Event
- November 11, 1999
- Report Date
- November 11, 1999
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GAG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT (1) EMS DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA PROCEDURE. IT WAS REPORTED BY THE REP THAT THE SURGEON USED AN EMS STAPLER TO PERFORM A HERNIORRHAPHY. THE STAPLER JAMMED AFTER THE 4TH STAPLE AND MISFIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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. | NA | 200409 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |