FDA Adverse Event
Malfunction
Summary report: N
PKS OMNI INSTRUMENT, 33CM
MDR report key: 1638683
·
Received March 17, 2010
Report
- Report Number
- 2183680-2010-00011
- Event Type
- Malfunction
- Date Received
- March 17, 2010
- Date of Event
- February 3, 2010
- Report Date
- March 17, 2010
- Manufacturer
- GYRUS MEDICAL INC.
- Product Code
- GEI
- PMA / PMN Number
- K081766
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN DISCARDED. 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
DURING A TLH PROCEDURE WHILE USING THE PKS OMNI INSTRUMENT, COAG WAS WEAK AND INEFFICIENT. COAG SETTINGS FROM 60-100 WERE WEAK ON EVEN THE SMALLER VESSELS. THE HOSPITAL G400 GENERATOR WAS USED AT THE HC2 SETTING. THE PATIENT BLED A LOT, BUT SUFFERED NO PATIENT HARM. THE SAME DEVICE WAS USED TO COMPLETE THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PKS OMNI INSTRUMENT, 33CM | PKS OMNI INSTRUMENT, 33CM | GEI | GYRUS MEDICAL INC. | 970010PC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |