FDA Adverse Event
Injury
Summary report: N
33CM PKS CUTTING FORCEPS
MDR report key: 3040049
·
Received April 3, 2013
Report
- Report Number
- 2183680-2013-00014
- Event Type
- Injury
- Date Received
- April 3, 2013
- Date of Event
- February 27, 2013
- Report Date
- March 4, 2013
- Manufacturer
- GYRUS MEDICAL INC
- Product Code
- GEI
- PMA / PMN Number
- K023492
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.
Description of Event or Problem · 1
DURING A SURGICAL PROCEDURE, THE DEVICE CAUSED A LITTLE BURN EFFECT CLOSE TO THE PATIENTS RIGHT LATERAL PERITONEUM THAT MAY HAVE EXTENDED TO THE VESICOUTERINE PERITONEUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136621 | 33CM PKS CUTTING FORCEPS | PKS CUTTING FORCEPS | GEI | GYRUS MEDICAL INC | 3005PK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |