FDA Adverse Event
Other
Summary report: N
33CM PKS OMNI INSTRUMENT
MDR report key: 1624638
·
Received March 5, 2010
Report
- Report Number
- 2183680-2010-00004
- Event Type
- Other
- Date Received
- March 5, 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 APPROXIMATELY 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 INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.
Description of Event or Problem · 1
A TLH PROCEDURE WAS PERFORMED ON A PATIENT USING THE PKS OMNI INSTRUMENT. THE PATIENT RETURNED TO THE EMERGENCY ROOM WHERE IT WAS DISCOVERED SHE HAD AN EMBOLISM. THE PATIENT WAS TREATED AT THE EMERGENCY ROOM AND WAS RELEASED.
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 |