FDA Adverse Event
Malfunction
Summary report: N
DISP PNCL W/HLSTR BULKPAK
MDR report key: 2539507
·
Received April 10, 2012
Report
- Report Number
- 1717344-2012-00480
- Event Type
- Malfunction
- Date Received
- April 10, 2012
- Report Date
- March 12, 2012
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE CAUTERY PENCIL ACTIVATED WHILE NOT IN USE. NO INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISP PNCL W/HLSTR BULKPAK | ES ACCESSORY - NON STERILE | GEI | COVIDIEN LP (VALLEYLAB) | 222116X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |