MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-10 for LIGHT SOURCE, 500XL, XENON 72200568 manufactured by Smith & Nephew, Inc..
[107975444]
Patient Sequence No: 1, Text Type: N, H10
[107975445]
It was reported that unit powered down in the middle of a procedure and would not power back on. A backup device was available to complete the procedure with no delay or patient injuries.
Patient Sequence No: 1, Text Type: D, B5
[114196825]
The device was received for evaluation. There was a relationship found between the returned device and the reported incident. A visual inspection was performed and a scratched lid was observed. A functional evaluation revealed the device did not power up. The complaint was confirmed and the root cause has been determined to be an electrical component failure of the power supply.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1643264-2018-00352 |
| MDR Report Key | 7503084 |
| Date Received | 2018-05-10 |
| Date of Report | 2018-07-17 |
| Date of Event | 2018-04-16 |
| Date Mfgr Received | 2018-07-16 |
| Date Added to Maude | 2018-05-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 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 | 2018-05-10 |
| Catalog Number | 72200568 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-10 |