FDA Adverse Event
Other
Summary report: N
ELITE SYSTEM & USA SERIES ROLLER BAR ELECTRODE
MDR report key: 1581104
·
Received January 14, 2010
Report
- Report Number
- 3006159227-2010-00001
- Event Type
- Other
- Date Received
- January 14, 2010
- Date of Event
- March 16, 2009
- Report Date
- January 14, 2010
- Manufacturer
- GYRUS ACMI INC.
- Product Code
- GEI
- PMA / PMN Number
- K890328
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN DISCARDED BY THE FACILITY. IF FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.
Description of Event or Problem · 1
DURING A HYSTEROSCOPIC ENDOMETRIAL ABLATION PROCEDURE USING THE ROLLER BAR ELECTRODE, THE PT SUFFERED A 3RD DEGREE BURN TO THE LEFT VULVA. INFORMATION FROM THE FACILITY REGARDING PT STATUS WAS THAT THE PT WAS IMPROVING, BUT HAD SOME DEGREE OF DYSPAREUNIA, ATTRIBUTABLE TO THE BURN. THE PHYSICIAN DEEMED THE INCIDENT DUE TO CAPACITIVE CONDUCTION, A KNOWN AND DOCUMENTED RISK TO THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELITE SYSTEM & USA SERIES ROLLER BAR ELECTRODE | ROLLER BAR ELECTRODE | GEI | GYRUS ACMI INC. | RB | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |