MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-04-23 for PILLING LIGHT SOURCE 52-147 manufactured by Teleflex.
[2748005]
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.
Patient Sequence No: 1, Text Type: D, B5
[9821159]
No sample is available for the manufacturer to evaluate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2012-00035 |
| MDR Report Key | 2551943 |
| Report Source | 05,06,07 |
| Date Received | 2012-04-23 |
| Date of Report | 2012-03-29 |
| Date of Event | 2012-01-24 |
| Date Mfgr Received | 2012-03-29 |
| Date Added to Maude | 2012-06-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | 2917 WECK DR. |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLING LIGHT SOURCE |
| Generic Name | LIGHT SOURCE, SURGICAL |
| Product Code | EQH |
| Date Received | 2012-04-23 |
| Catalog Number | 52-147 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-23 |