FDA Adverse Event
Injury
Summary report: N
CERAMIC ELECTRODE TIP J-HK F/GK372R
MDR report key: 545010
·
Received September 20, 2004
Report
- Report Number
- 2916714-2004-00034
- Event Type
- Injury
- Date Received
- September 20, 2004
- Date of Event
- August 19, 2004
- Report Date
- September 17, 2004
- Manufacturer
- AESCULAP AG & CO. KG
- Product Code
- GEI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
GALLBLADDER SURGERY. IT WAS NOTICED AFTERWARD THAT J-HOOK (GK383R USED WITH HANDLE GK372R) WAS MISSING. X-RAYS CONFIRMED PIECE WAS IN PATIENT. RESURGERY WAS PERFORMED THE NEXT DAY AND J-HOOK WAS REMOVED. USED FLUORSCOPY TO IDENTIFY PART. PATIENT WAS ADMITTED FOR OBSERVATION. PATIENT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CERAMIC ELECTRODE TIP J-HK F/GK372R | ACCESSORIES FOR COAGULATION | GEI | AESCULAP AG & CO. KG | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |