FDA Adverse Event
Malfunction
Summary report: N
DISP PNCL W/HLSTR BULKPAK
MDR report key: 1639157
·
Received March 9, 2010
Report
- Report Number
- 1717344-2010-00147
- Event Type
- Malfunction
- Date Received
- March 9, 2010
- Date of Event
- February 4, 2010
- Report Date
- February 10, 2010
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A TRIPLE A (ABDOMINAL AORTIC ANEURYSM) REPAIR PROCEDURE, THE PT WAS BURNED. A BREAK IN THE INSULATION OF THE BOVIE CORD MAY HAVE CAUSED AN ARC THROUGH THE TOWEL CLIP TO THE SKIN. THE OR REPORTED THAT THE CORD WAS "KINKED" AND THE ARC REPORTEDLY CAME FROM THE "KINK". THE PT HAD A 1 CM CIRCULAR FULL THICKNESS, 2ND DEGREE BURN ON THE ANTEROLATERAL ASPECT OF THE RIGHT THIGH. IT WAS UNK WHERE THE PT RETURN PAD WAS PLACED. THE PT WAS TREATED WITH SILVADENE AND RELEASED FROM THE HOSP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISP PNCL W/HLSTR BULKPAK | ELECTROSURGICAL ACCESSORY | GEI | COVIDIEN LP (VALLEYLAB) | 166050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | E7506 - NON REM PT RETURN ELECTRODE - LOT# UNK |