MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-07-21 for FIBEROTPIC LIGHT CABLE 8061.456 manufactured by Richard Wolf Medical Instruments Corp..
[21957242]
When a laparoscopy procedure was completed, operating room personnel found a burn mark on the surgical drape. The burn was at a spot where the flexible part of a fiberoptic light cable was resting during the case. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2004-00022 |
| MDR Report Key | 613579 |
| Report Source | 05 |
| Date Received | 2004-07-21 |
| Date of Report | 2004-06-22 |
| Date of Event | 2004-06-21 |
| Date Facility Aware | 2004-06-21 |
| Report Date | 2004-06-22 |
| Date Reported to Mfgr | 2004-06-22 |
| Date Mfgr Received | 2004-06-22 |
| Device Manufacturer Date | 2002-03-01 |
| Date Added to Maude | 2005-06-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JERRY BALOK |
| Manufacturer Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479131113 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIBEROTPIC LIGHT CABLE |
| Generic Name | FIBEROPTIC LIGHT CABLE |
| Product Code | EQH |
| Date Received | 2004-07-21 |
| Returned To Mfg | 2004-06-29 |
| Model Number | 8061.456 |
| Catalog Number | 8061.456 |
| Lot Number | 184M02 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 603405 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Manufacturer Address | 353 CORPORATE WOODS PKWY. VERNON HILLS IL 60061 US |
| Baseline Brand Name | FIBEROPTIC LIGHT CABLE |
| Baseline Generic Name | FIBEROPTIC LIGHT CABLE |
| Baseline Model No | 8061.456 |
| Baseline Catalog No | 8061.456 |
| Baseline ID | 184M02 |
| Baseline Device Family | FIBEROPTIC LIGHT CABLE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-07-21 |