FDA Adverse Event
Malfunction
Summary report: N
MONOPOLAR RETURN ELECTRODE CABLE
MDR report key: 2230961
·
Received July 19, 2011
Report
- Report Number
- 1811755-2011-02600
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- July 6, 2011
- Report Date
- July 7, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- GXD
- PMA / PMN Number
- K032406
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR AN INVESTIGATION. A FOLLOW UP REPORT WILL BE MADE IF THE PRODUCT IS RETURNED, AND IF THE INVESTIGATION REQUIRES.
Description of Event or Problem · 1
DURING AN RF PROCEDURE, THE GROUND PAD CABLE DID NOT WORK PROPERLY. TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL AND BACK UP EQUIPMENT WAS NOT AVAILABLE. THE PT HAD ALREADY BEEN GIVEN LOCAL ANESTHETIC WHEN IT WAS DECIDED TO CANCEL THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE REPORTED AS A RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MONOPOLAR RETURN ELECTRODE CABLE | GXD | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |