FDA Adverse Event
Malfunction
Summary report: N
DISP BTTN PNCL BULKPAK
MDR report key: 2764669
·
Received September 21, 2012
Report
- Report Number
- 1717344-2012-00996
- Event Type
- Malfunction
- Date Received
- September 21, 2012
- Report Date
- August 23, 2012
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DATE OF INITIAL REPORT: (B)(6) 2012. TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING SURGERY, THE CAUTERY PENCIL REMAINED ACTIVATED EVEN WHEN THE SURGEON WAS NOT PRESSING THE BUTTON. THERE WAS NO HARM TO PT OR PERSONNEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISP BTTN PNCL BULKPAK | ES ACCESSORY, NON-STERILE | GEI | COVIDIEN LP (VALLEYLAB) | 232183X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |