FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ENDOSCOPIC MULTIFEED STAPLER
MDR report key: 174070
·
Received June 23, 1998
Report
- Report Number
- 1527736-1998-01797
- Event Type
- Malfunction
- Date Received
- June 23, 1998
- Report Date
- March 26, 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TRACKING #.50846. EES #.982180/J. D5; H4: INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ENDOSCOPIC MULTIFEED STAPLER WAS USED DURING A HERNIA REPAIR PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT 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 | K47N83 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |