FDA Adverse Event
Other
Summary report: N
33CM PKS OMNI INSTRUMENT
MDR report key: 1624733
·
Received March 4, 2010
Report
- Report Number
- 2183680-2010-00005
- Event Type
- Other
- Date Received
- March 4, 2010
- Date of Event
- November 1, 2009
- Report Date
- March 4, 2010
- Manufacturer
- GYRUS MEDICAL INC.
- Product Code
- GEI
- PMA / PMN Number
- K081766
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AS THE DEHISCENCE WAS NOT DETECTED UNTIL APPROX SIX WEEKS POST-OP, THE DEVICE WAS DISCARDED BY THE FACILITY AFTER THE PROCEDURE WAS COMPLETED. AS A RESULT, A DETERMINATION CANNOT BE MADE. IF FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.
Description of Event or Problem · 1
DURING A POST-OP VISIT FOLLOWING A TLH PROCEDURE WHERE THE PKS OMNI INSTRUMENT WAS USED, THE SURGEON DISCOVERED THAT THE PT SUFFERED FROM CUFF DEHISCENCE. THE PT SUFFERED WITH VAGINAL DISCHARGE. THE DEHISCENCE WAS NOT DETECTED UNTIL APPROX 6 WEEKS POST-OP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 33CM PKS OMNI INSTRUMENT | PKS OMNI INSTRUMENT, 33CM | GEI | GYRUS MEDICAL INC. | 970010PC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |