MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-19 for X8000 LIGHTSOURCE 0220200000 manufactured by Stryker Endoscopy-san Jose.
[5139597]
It was reported that there was an alleged current on the outer surface of the light source.
Patient Sequence No: 1, Text Type: D, B5
[12615471]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[26660287]
The device(s) was not received for investigation at stryker endoscopy because it was repaired locally in (b)(4). Current is being sensed on outer surface of x8000 light source. The device was repaired and there is no longer any current being sensed on the surface. The reported event involving this failure and device could have been caused by: improper assembly; external fluids enter unit; defective connectors; improper grounding; use error. In sum, the reported failure was confirmed at (b)(6). The product was returned for investigation and the reported failure mode was confirmed. The failure mode will be monitored for future reoccurrence.???????
Patient Sequence No: 1, Text Type: N, H10
[26660288]
It was reported that there was an alleged current on the outer surface of the light source.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2014-01030 |
| MDR Report Key | 4348611 |
| Report Source | 05 |
| Date Received | 2014-12-19 |
| Date of Report | 2014-11-24 |
| Date of Event | 2014-11-21 |
| Date Mfgr Received | 2014-11-24 |
| Date Added to Maude | 2015-01-06 |
| 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 | X8000 LIGHTSOURCE |
| Generic Name | LIGHT, SURGICAL, FLOOR STANDING |
| Product Code | FSS |
| Date Received | 2014-12-19 |
| Catalog Number | 0220200000 |
| Operator | OTHER |
| 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 | 2014-12-19 |