MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-11 for LIGHT SOURCE, 500XL, XENON 72200568 manufactured by Smith & Nephew, Inc..
[97055111]
Patient Sequence No: 1, Text Type: N, H10
[97055112]
It was reported that when the device was turned on before the procedure, the device had a power down suddenly with a explosive sound. The procedure was complete with a back-up device. After the problem happened, the device was inspected at our service team. It was confirmed that one of the cooling fan stopped working when the lamp illuminated.
Patient Sequence No: 1, Text Type: D, B5
[135369204]
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting. The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event. This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1643264-2018-00036 |
| MDR Report Key | 7181485 |
| Date Received | 2018-01-11 |
| Date of Report | 2018-02-20 |
| Date of Event | 2017-12-19 |
| Date Mfgr Received | 2018-02-19 |
| Date Added to Maude | 2018-01-11 |
| 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 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 | 2018-01-11 |
| Model Number | 72200568 |
| 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 | 2018-01-11 |