MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-10-16 for PILLING HEAD LAMP CABLE W358LWA manufactured by Teleflex Medical.
[19002095]
Eval results: no hole was found in the cable. Internal fiber breakage with no possibility of surgeon burning back. Internal fiber breakage. Conclusion: aculux, the manufacturer, states that cause of breakage could be due to the cable was coiled improperly or rolled over with cart/floorstand.
Patient Sequence No: 1, Text Type: N, H10
[19056614]
The complaint description was reported as: the surgeon was using the headset and cable when he felt a burning sensation on his back. The circulating nurse looked at his back and saw that there was a hole in the cable, and light was coming through this hole and burning the surgeon's back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1044475-2008-00035 |
| MDR Report Key | 1202786 |
| Report Source | 05,07 |
| Date Received | 2008-10-16 |
| Date of Report | 2008-09-25 |
| Date of Event | 2008-09-24 |
| Date Mfgr Received | 2008-09-25 |
| Date Added to Maude | 2010-05-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANGELA BROWN, MGR. |
| Manufacturer Street | 4024 STIRRUP CREEK DR. |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | 9194334901 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27703 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLING HEAD LAMP CABLE |
| Generic Name | HEAD LAMP CABLE |
| Product Code | EBA |
| Date Received | 2008-10-16 |
| Returned To Mfg | 2008-10-06 |
| Model Number | NA |
| Catalog Number | W358LWA |
| Lot Number | 5072-41 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC 27703 US 27703 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-16 |