MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-10-16 for FIBEROPTIC LIGHT CABLE 8061.456 manufactured by Richard Wolf Medical Instruments.
[1305824]
It was reported that during a laparoscopic cholecystectomy, the fiber light cable caused a 1. 000 inch x. 250 inch burn on the patient's abdomen. The appearance was of a 'bubble' without redness. Antibiotic ointment was applied to the burn.
Patient Sequence No: 1, Text Type: D, B5
[8284969]
Evaluation summary - 8061. 456 - fiberoptic light cable, 4. 5mm - lot#: 184o02. The fiberoptic light cable was checked for light output and results were low light output. The adapter on the cable was loose and the ring was discolored. There were visible broken fibers with brownish color. The appearance of the cable shows wear and tear. The cable has been in use for approximately (7) seven years. The cable was returned to the customer, per their request, as is. Cause: unusual, however, we believe the broken end fibers allowed projected light to shine through the rubber insulation and heat up the rubber material.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2009-00013 |
| MDR Report Key | 1517765 |
| Report Source | 05,06 |
| Date Received | 2009-10-16 |
| Date of Report | 2009-10-16 |
| Date of Event | 2009-09-17 |
| Date Mfgr Received | 2009-09-23 |
| Device Manufacturer Date | 2002-10-01 |
| Date Added to Maude | 2010-09-07 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELEANOR HALL |
| Manufacturer Street | 353 CORPORATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479558016 |
| Manufacturer G1 | RICHARD WOLF MEDICAL INSTRUMENTS |
| Manufacturer Street | 353 CORPORATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIBEROPTIC LIGHT CABLE |
| Generic Name | FIBEROPTIC LIGHT CABLE |
| Product Code | EQH |
| Date Received | 2009-10-16 |
| Returned To Mfg | 2009-09-25 |
| Model Number | 8061.456 |
| Catalog Number | 8061.456 |
| Lot Number | 184O02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS |
| Manufacturer Address | VERNON HILLS IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-16 |