MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-12-03 for 5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE 0233050069 manufactured by Stryker Endoscopy-san Jose.
[4829787]
It was reported that during a surgery the lightsource with a used fiberoptic cable overheated and burned the patient's leg. Furthermore, the sterile area was damaged due to burns. A second surgery was conducted with another cable and the same issue occurred.
Patient Sequence No: 1, Text Type: D, B5
[12189291]
The device was returned to stryker for investigation, but the customer complaint of? Overheating? Was not confirmed. The failure mode was due to a defective x8000 lightsource not the light cable. Visual inspection revealed long usage discoloration of the outer sheath and a functional inspection revealed the cable when illuminated had excessive broken fibers. As previously stated the root cause was a defective x8000 light source. The product was returned for investigation, but the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence.
Patient Sequence No: 1, Text Type: N, H10
[20857783]
It was reported that during a surgery the lightsource with a used fiberoptic cable overheated and burned the patient's leg. Furthermore, the sterile area was damaged due to burns. A second surgery was conducted with another cable and the same issue occurred.
Patient Sequence No: 1, Text Type: D, B5
[21279273]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002936485-2013-00547 |
| MDR Report Key | 3496093 |
| Report Source | 05 |
| Date Received | 2013-12-03 |
| Date of Report | 2013-11-06 |
| Date of Event | 2013-10-30 |
| Date Mfgr Received | 2013-11-06 |
| Date Added to Maude | 2013-12-03 |
| 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 | MR. THOMAS SHAFER |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE |
| Generic Name | LIGHT, SURGICAL, FLOOR STANDING |
| Product Code | FSS |
| Date Received | 2013-12-03 |
| Returned To Mfg | 2014-01-03 |
| Catalog Number | 0233050069 |
| Lot Number | 335U |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-03 |