FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ENDOSCOPIC MULTIFEED STAPLER
MDR report key: 154638
·
Received March 4, 1998
Report
- Report Number
- 1527736-1998-00601
- Event Type
- Malfunction
- Date Received
- March 4, 1998
- Date of Event
- February 4, 1998
- Report Date
- February 4, 1998
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GAG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TRACKING #.49590. EES #.981075/J. ENDOPATH ENDOSCOPIC MULTIFEED STAPLER: BASED ON THE INQUIRY INFO RECEIVED, VISUAL EXAMINATION AND FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE REPORTED EVENT DURING SURGERY OCCURRED DUE TO A PARTIALLY YIELDED CARTRIDGE NOSE WELD. THE INSTRUMENT WAS RECEIVED WITH A PARTIALLY YIELDED NOSE WELD WHICH WOULD NOT ALLOW THE FOLLOWING STAPLES TO PROPERLY FEED INTO THE NOSE TO FIRE. NO CONCLUSION COULD BE REACHED AS TO HOW THE NOSE WELD HAD YIELDED.
Description of Event or Problem · 1
IT WAS REPORTED THE EMS WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED BY THE AFFILIATE ONE CLIP WAS FIRED AND DRIVES DID NOT PROMOTE ANY FURTHER CLIPS. ANOTHER EMS WAS OPENED 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 | ENDOSCOPIC STAPLER | GAG | ETHICON ENDO-SURGERY, INC. | NA | K48G6X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |