MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-03-08 for 5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE 0233050064 manufactured by Stryker Endoscopy-san Jose.
[3193064]
It was reported that the light lead was plugged into a light box and immediately became hot. It was further reported that the light lead burnt the operating table mattress.
Patient Sequence No: 1, Text Type: D, B5
[3513913]
It was reported that the light lead was plugged into a light box and immediately became hot. It was further reported that the light lead burnt the operating table mattress.
Patient Sequence No: 1, Text Type: D, B5
[10552321]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[10747442]
The product was returned for investigation. The reported failure mode could not be confirmed. The unit was found to have excessive broken fibers and a yellowish tint to the outer sheath; those conditions indicate long usage. Measurements were performed and the results concluded that the cable was not in functional condition and should not have been used. Finally, the product had lower temperature output as compared to a new out-of-box cable. It should also be noted that the product was used with a non-stryker product which could have contributed to the reported failure. In sum, the product was returned for investigation but the reported failure could not be confirmed. The failure mode will be monitored for future reoccurrence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002936485-2013-00054 |
| MDR Report Key | 2995846 |
| Report Source | 00 |
| Date Received | 2013-03-08 |
| Date of Report | 2013-02-11 |
| Date of Event | 2012-12-28 |
| Date Mfgr Received | 2013-02-11 |
| Date Added to Maude | 2013-05-14 |
| 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 | 2013-03-08 |
| Returned To Mfg | 2013-03-07 |
| Catalog Number | 0233050064 |
| Lot Number | 175Q |
| 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 | 2013-03-08 |