MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-18 for LIGHT SOURCE, 500XL, XENON 72200568 manufactured by Smith & Nephew, Inc..
[133721979]
Patient Sequence No: 1, Text Type: N, H10
[133721980]
It was reported that the device was overheating.
Patient Sequence No: 1, Text Type: D, B5
[138775280]
The device was received for evaluation. There was no relationship found between the returned device and the reported incident. A visual inspection was performed on the product and no issue was observed. Complaint of overheating could not be reproduced. Product passed functional testing and 4 hour burn-in with no overheating. All functions perform as expected and light output was steady and continuous. The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process. A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1643264-2019-00061 |
| MDR Report Key | 8262435 |
| Date Received | 2019-01-18 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-01-10 |
| Date Mfgr Received | 2019-03-08 |
| Date Added to Maude | 2019-01-18 |
| 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 WEST 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 | 2019-01-18 |
| Returned To Mfg | 2019-01-18 |
| 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 | 2019-01-18 |