MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-15 for LIGHT CABLE UNK * manufactured by Stryker Endoscopy San Jose.
[17868203]
It was reported that at the end of the procedure, the physician handed the scope to the scrub tech and asked for the light to be turned off. The light cord was put down on the drape. Moments later a black hole in the drape was noticed. The drape was removed and the pt was found to have a burn on the lower lip. The hosp is not sure if the light cord is a stryker cable or one mfg by spectrum surgical instruments or richard wolf.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 809894 |
| MDR Report Key | 809894 |
| Date Received | 2007-01-15 |
| Date of Report | 2006-12-21 |
| Date of Event | 2006-12-11 |
| Date Added to Maude | 2007-01-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHT CABLE |
| Generic Name | LIGHT CABLE |
| Product Code | FFZ |
| Date Received | 2007-01-15 |
| Model Number | UNK |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 797391 |
| Manufacturer | STRYKER ENDOSCOPY SAN JOSE |
| Manufacturer Address | * SAN JOSE CA 95138 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-01-15 |