FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ENDOSCOPIC MULTIFEED STAPLER
MDR report key: 148379
·
Received February 6, 1998
Report
- Report Number
- 1527736-1998-00120
- Event Type
- Malfunction
- Date Received
- February 6, 1998
- Report Date
- January 8, 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 #.48491. EES #.980193/J. ENDOPATH ENDOSCOPIC MULTIFEED STAPLER: BASED UPON INQUIRY INFO RECEIVED AND VISUAL EXAMINATION NO CONCLUSION COULD BE REACHED AS TO HOW THE REPORTED EVENT OCCURRED. THE INSTRUMENT WAS RECEIVED WITH A HALF OF THE HEAD HOUSING MISSING, DRIVER WAS BENT AND WITH ONE STAPLE IN THE NOSE IN THE FIRING POSITION AND THE NOSE WAS IN GOOD CONDITION. THE INSTRUMENT WAS DISASSEMBLED AND 22 STAPLES WERE FOUND IN THE TRACK. NO CONCLUSION COULD BE REACHED AS TO HOW THE HEAD HOUSING HAD BROKEN.
Description of Event or Problem · 1
IT WAS REPORTED THE EMS WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED BY THE AFFILIATE THE STAPLES WERE NOT DELIVERED. 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 | K4813M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |