MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-12-05 for LIGHT SOURCE, 500XL, XENON 72200568 manufactured by Smith & Nephew, Inc..
[129475458]
Patient Sequence No: 1, Text Type: N, H10
[129475459]
It was reported that the light source turned off in the middle of the surgery. A backup device was available to complete the procedure with no significant delay and no patient injuries.
Patient Sequence No: 1, Text Type: D, B5
[136634055]
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. No containment or corrective actions are recommended at this time. A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended. 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 | 1643264-2018-00935 |
| MDR Report Key | 8133111 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-05 |
| Date of Report | 2019-02-06 |
| Date of Event | 2018-11-28 |
| Date Mfgr Received | 2019-02-05 |
| Date Added to Maude | 2018-12-05 |
| 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 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 | 3 |
| Brand Name | LIGHT SOURCE, 500XL, XENON |
| Generic Name | IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE |
| Product Code | FFS |
| Date Received | 2018-12-05 |
| Catalog Number | 72200568 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-12-05 |