FDA Adverse Event
Malfunction
Summary report: N
PILLING LIGHT SOURCE
MDR report key: 2551943
·
Received April 23, 2012
Report
- Report Number
- 1044475-2012-00035
- Event Type
- Malfunction
- Date Received
- April 23, 2012
- Date of Event
- January 24, 2012
- Report Date
- March 29, 2012
- Manufacturer
- TELEFLEX
- Product Code
- EQH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE IS AVAILABLE FOR THE MANUFACTURER TO EVALUATE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: PER MEDWATCH REPORT: DURING A SURGICAL PROCEDURE, THE PILLING LIGHT SOURCE STARTED SMOKING. THE LIGHT WAS IMMEDIATELY UNPLUGGED AND REMOVED FROM SERVICE. THE LIGHT WAS EXAMINED AND IT WAS DETERMINED THAT IT WAS DAMAGED BEYOND REPAIR AND ALSO TOO OLD (>25 YEARS OLD). THE LIGHT WAS DISPOSED. THERE WAS NO INJURY TO THE PT OR STAFF. NO PT INJURY REPORTED. PT'S CURRENT CONDITION IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PILLING LIGHT SOURCE | LIGHT SOURCE, SURGICAL | EQH | TELEFLEX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |