MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-05-06 for 5.0MM X 10FT FIBEROPTIC LIGHT CABLE 0233065010 manufactured by Stryker Endoscopy-san Jose.
[4476199]
It was reported that the light cable was turned causing it to touch the patient's abdomen, which allegedly caused a surface burn.
Patient Sequence No: 1, Text Type: D, B5
[11882073]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[19972787]
It was reported that the light cable was turned causing it to touch the patient's abdomen, which allegedly caused a surface burn.
Patient Sequence No: 1, Text Type: D, B5
[20305956]
The device was not returned to stryker endo for investigation. A detailed investigation cannot be performed without the unit, this complaint will be closed as unit not received and based on a probable root cause. In the event that if the unit is returned to stryker endo, we will reopen the investigation for further analysis. Based on previous investigations and the risk document, a probable root cause may be too much heat generated from the light source. The product was not returned for investigation and the reported failure mode could not be confirmed. The failure mode will be monitored for future reoccurrence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002936485-2014-00308 |
| MDR Report Key | 3793982 |
| Report Source | 07 |
| Date Received | 2014-05-06 |
| Date of Report | 2014-03-18 |
| Date of Event | 2014-03-14 |
| Date Mfgr Received | 2014-03-18 |
| Date Added to Maude | 2014-05-06 |
| 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 FIBEROPTIC LIGHT CABLE |
| Generic Name | LIGHT, SURGICAL, FLOOR STANDING |
| Product Code | FSS |
| Date Received | 2014-05-06 |
| Catalog Number | 0233065010 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-05-06 |