FDA Adverse Event
Malfunction
Summary report: N
PLS CUTTING FORCEPS
MDR report key: 3459142
·
Received October 8, 2013
Report
- Report Number
- 2183680-2013-00052
- Event Type
- Malfunction
- Date Received
- October 8, 2013
- Date of Event
- September 4, 2013
- Report Date
- September 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
- LA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. 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
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO OF THE SAME LOT DEVICE MALFUNCTIONED, CREATED A DELAY AND CAUSED EXCESSIVE BLEEDING. A THIRD WAS USED FROM A DIFFERENT LOT AND FUNCTIONED NORMALLY, THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. (OTHER DEVICE ON MFR. REPORT # 2183680-2013-00051).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 510481 | PLS CUTTING FORCEPS | PKS CUTTING FORCEPS | GEI | GYRUS MEDICAL, INC. | 920005PK | JF67754 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other| R |