MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-04-10 for X8000 LIGHTSOURCE 0220200000 manufactured by Stryker Endoscopy-san Jose.
[17296406]
The endoscopy tip burned two patients in one month period.
Patient Sequence No: 1, Text Type: D, B5
[17457756]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[33373977]
The reported device was not received for investigation; therefore the reported failure cannot be confirmed. The complaint will be closed without a detailed investigation report and based on probable root cause. In the event that the device is received, the complaint will be reopened, a full evaluation will be conducted, and the investigation will be updated with the new results. Probable root cause for the reported failure involving this device could have been caused by: bulb assembly, ballast, control board, ac inlet board, reed switch, thermal switch, ballast connector, beam sensor, fuses, front panel membrane switch, esst components, motor assembly, sidne input, light post, em interference. Use errors: the product was not returned for investigation therefore the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence.
Patient Sequence No: 1, Text Type: N, H10
[33373978]
The endoscopy tip burned two patients in one month period.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2015-00285 |
| MDR Report Key | 4682581 |
| Report Source | 07 |
| Date Received | 2015-04-10 |
| Date of Report | 2015-03-31 |
| Date of Event | 2015-03-30 |
| Date Mfgr Received | 2015-03-31 |
| Date Added to Maude | 2015-04-13 |
| 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 | X8000 LIGHTSOURCE |
| Generic Name | LIGHT, SURGICAL, FLOOR STANDING |
| Product Code | FSS |
| Date Received | 2015-04-10 |
| Catalog Number | 0220200000 |
| 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 | 1. Other | 2015-04-10 |