MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-06-03 for X8000 LIGHTSOURCE 0220200000 manufactured by Stryker Endoscopy-san Jose.
[3524307]
It was reported by sales representative that upon getting power a small explosion and smoke came out of the unit. This triggered the fire alarm after several seconds.
Patient Sequence No: 1, Text Type: D, B5
[3954482]
It was reported by sales representative that upon getting power a small explosion and smoke came out of the unit. This triggered the fire alarm after several seconds.
Patient Sequence No: 1, Text Type: D, B5
[10788108]
Additional information will be provided once investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[11135481]
The product was returned for investigation. The reported failure mode was confirmed. Cosmetic inspection confirmed no outward signs of damage and also no loose parts/items. The unit failed to power up, therefore, functionality tests could not be performed. The fuses were blown and further inspection of the ballast power supply revealed that ballast power capacitor had released the electrolytic fluid through the pressure release vents. This failure does not endanger the user because the capacitor releases the pressure by design and the fuses blow to protect the unit. This failure has occurred in the past due to a very old revision ballast. In this case the ballast was an older revision which is over 6 years old. 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 | 0002936485-2013-00246 |
| MDR Report Key | 3143599 |
| Report Source | 07 |
| Date Received | 2013-06-03 |
| Date of Report | 2013-05-17 |
| Date of Event | 2013-05-13 |
| Date Mfgr Received | 2013-05-17 |
| Date Added to Maude | 2013-08-21 |
| 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 | 2013-06-03 |
| Catalog Number | 0220200000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2013-06-03 |