MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-12 for LIGHT SOURCE, 500XL, XENON 72200568 manufactured by Smith & Nephew, Inc..
[130202458]
Patient Sequence No: 1, Text Type: N, H10
[130202459]
It was reported that during a procedure, the power cord of light source 500xl burned during the operation. The place in which the fire started was at a part of a multi plug of power strip. The customer exchanged the power cord and re-connected with another power source, the device was successfully booted. The procedure was completed without patient injuries and complications.
Patient Sequence No: 1, Text Type: D, B5
[135495866]
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed. A relationship, if any, between the subject device and the reported event could not be determined. If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1643264-2018-00977 |
| MDR Report Key | 8154846 |
| Date Received | 2018-12-12 |
| Date of Report | 2019-02-06 |
| Date of Event | 2018-12-07 |
| Date Mfgr Received | 2019-02-05 |
| Date Added to Maude | 2018-12-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JIM GONZALES |
| Manufacturer Street | 7000 W. WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 76 S. MERIDIAN AVE. |
| Manufacturer City | OKLAHOMA CITY OK 731076512 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 731076512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIGHT SOURCE, 500XL, XENON |
| Generic Name | IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE |
| Product Code | FFS |
| Date Received | 2018-12-12 |
| Returned To Mfg | 2019-02-15 |
| Catalog Number | 72200568 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 76 S. MERIDIAN AVE. OKLAHOMA CITY OK 731076512 US 731076512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-12 |