MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-11-13 for KIT, X8000 LIGHTSOURCE, EUROPE 0220200000E manufactured by Stryker Endoscopy-san Jose.
[3853459]
It was reported that the drape on the patient got burned and the skin underneath got slightly burned. The scope was not connected and the cable was placed on the drape. The light source was on and the lighting was set at 80. The burn on the skin was light so the procedure was continued and completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[11414294]
The product was not returned for investigation. The reported failure mode could not be confirmed. Based on previous investigations with the same failure mode, the most probable root cause can be determined to be due to user error. However, this cannot be confirmed since the unit was not returned. In the event that the unit is returned, a full evaluation will be conducted a follow up report will be issued. In sum, the product was not returned for investigation and the reported failure mode could not be confirmed. The failure mode will be monitored for future reoccurrence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002936485-2013-00490 |
| MDR Report Key | 3467976 |
| Report Source | 07 |
| Date Received | 2013-11-13 |
| Date of Report | 2013-04-24 |
| Date of Event | 2013-04-24 |
| Date Mfgr Received | 2013-04-24 |
| Date Added to Maude | 2013-11-14 |
| 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 | 0 |
| 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 | KIT, X8000 LIGHTSOURCE, EUROPE |
| Generic Name | LIGHT, SURGICAL, FLOOR STANDING |
| Product Code | GDB |
| Date Received | 2013-11-13 |
| Catalog Number | 0220200000E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2013-11-13 |