FDA Adverse Event
Injury
Summary report: N
33CM CUTTING FORCEPS, 5MM
MDR report key: 2538911
·
Received April 11, 2012
Report
- Report Number
- 2183680-2012-00021
- Event Type
- Injury
- Date Received
- April 11, 2012
- Date of Event
- March 16, 2012
- Report Date
- March 16, 2012
- Manufacturer
- GYRUS MEDICAL INC
- Product Code
- GEI
- PMA / PMN Number
- K0423492
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSP HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.
Description of Event or Problem · 1
DURING A GYNECOLOGY LAPAROSCOPIC CASE, HALF WAY THROUGH THE PROCEDURE THE SURGEON NOTICED SPARKING FROM THE BLACK SHEATH THAT SLIDES INTO THE SHAFT ON THE AREA BEFORE THE METAL TONGS. SPARKS DID NOT BURN THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 33CM CUTTING FORCEPS, 5MM | CUTTING FORCEPS | GEI | GYRUS MEDICAL INC | 3005 | 121049HB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |