MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-08-05 for X7000 XENON LIGHTSOURCE 0220190000 manufactured by Stryker Endoscopy-san Jose.
[17616861]
It was reported that the lightsource automatically switched to standby intermittently. The procedure was later switched to an open surgery.
Patient Sequence No: 1, Text Type: D, B5
[17811748]
Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[30273333]
X7000 s/n (b)(4) was returned to stryker for analysis, but the failure mode was not confirmed. The customer complaint of? Switched to standby? Could not be duplicated. Visual inspection: there were no outward signs of cosmetic or physical damage to the product. Functional inspection: all measurements and functionality testing met specification. Probable root cause: could not duplicate the complaint in our test environment. In sum, the unit was returned, but the failure mode was not confirmed.
Patient Sequence No: 1, Text Type: N, H10
[30273334]
It was reported that the lightsource automatically switched to standby intermittently. The procedure was later switched to an open surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2014-00576 |
| MDR Report Key | 3982333 |
| Report Source | 07 |
| Date Received | 2014-08-05 |
| Date of Report | 2014-07-09 |
| Date of Event | 2014-07-09 |
| Date Mfgr Received | 2014-07-09 |
| Date Added to Maude | 2014-08-14 |
| 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 | X7000 XENON LIGHTSOURCE |
| Generic Name | LIGHT, SURGICAL, FLOOR STANDING |
| Product Code | FSS |
| Date Received | 2014-08-05 |
| Returned To Mfg | 2014-07-28 |
| Catalog Number | 0220190000 |
| 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 | 2014-08-05 |