MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-17 for KARL STORZ LIGHT CABLE 495NL manufactured by Karl Storz Endovision.
[348026]
Pt in o. R. For diagnostic laparoscopy. Light source turned on (circulator though she heard to turn it on). Light source was not ready to be used so cable was laid on drape covering pt face. Light cable burned hole in drape and pt sustained burn to left cheek. Pt seen by plastic surgeon. Burn appears to be third degree at center.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020550-2005-00001 |
| MDR Report Key | 567268 |
| Date Received | 2005-01-17 |
| Date of Report | 2005-01-17 |
| Date of Event | 2004-11-17 |
| Date Facility Aware | 2004-12-21 |
| Report Date | 2005-01-17 |
| Date Reported to FDA | 2005-01-17 |
| Date Reported to Mfgr | 2005-01-17 |
| Date Added to Maude | 2005-01-26 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ LIGHT CABLE |
| Generic Name | LIGHT CABLE |
| Product Code | FFZ |
| Date Received | 2005-01-17 |
| Model Number | 495NL |
| Catalog Number | 495NL |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 557080 |
| Manufacturer | KARL STORZ ENDOVISION |
| Manufacturer Address | 91 CARPENTER HILL RD. CHARLTON MA 01507 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-01-17 |