MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-03-28 for X7000 XENON LIGHTSOURCE 0220190000 manufactured by Stryker Endoscopy-san Jose.
[3257783]
It was reported that the device would go in and out of standby.
Patient Sequence No: 1, Text Type: D, B5
[3714235]
It was reported that the device would go in and out of standby.
Patient Sequence No: 1, Text Type: D, B5
[10588674]
Additional information will be provided once the investigation has been completed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[11109588]
The product was returned for investigation. The reported failure mode was confirmed. Visual inspection confirmed there were no outward signs of damage and also no loose parts/items. Initial power sequence included: powering up; confirming display activity; loading correct software; standby mode check; bulb ignition; error code check; repeating sequence several times. Functionality testing included: standby/run mode cycling; variability of light intensity; esst/scope disconnect; cable/jaw engagement; door/bulb ignition cycling, front panel functions. Standby/run mode cycling failed to maintain activate mode. Measurements and burn-in test were deemed inapplicable, the failure was confirmed. The unit would intermittently loose light output and drop to standby mode. The unit had unstable power output to the bulb from the ballast power supply. The unit is over (7) years old and has not been returned for service or upgrades. The ballast failure is due to long usage component breakdown and not an isolated failure mode. The product will be sent to service for repair and disposition per in-house procedures. In sum, 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
| Report Number | 0002936485-2013-00105 |
| MDR Report Key | 3026692 |
| Report Source | 06 |
| Date Received | 2013-03-28 |
| Date of Report | 2013-03-05 |
| Date of Event | 2013-03-05 |
| Date Mfgr Received | 2013-03-05 |
| Date Added to Maude | 2013-05-29 |
| 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 | 2013-03-28 |
| Returned To Mfg | 2013-03-20 |
| Catalog Number | 0220190000 |
| Operator | OTHER |
| 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 | 2013-03-28 |