FDA Adverse Event
Malfunction
Summary report: N
STRYKER ENDOSCOPY
MDR report key: 477268
·
Received August 4, 2003
Report
- Report Number
- MW1029225
- Event Type
- Malfunction
- Date Received
- August 4, 2003
- Date of Event
- May 19, 2003
- Report Date
- August 1, 2003
- Manufacturer
- STRYKER ENDOSCOPY
- Product Code
- KOG
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AZ, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR. IN PROCESS OF DISSECTING, ENDOSHEARS SCISSORS BROKE; PART WAS RETRIEVED IMMEDIATELY. AREA AROUND HINGE PIN HAD CRACKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRYKER ENDOSCOPY | INSERT OF ENDOSHEARS | KOG | STRYKER ENDOSCOPY | 250-080-267 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR |