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 2020-01-02 for SYSTEM, LIGHT SOURCE, 500XL, ENGLISH 72200580 manufactured by Smith & Nephew, Inc..
[175912213]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[175912214]
It was reported that the light source malfunctioned during a surgery. The procedure was completed using a competitor device and there was a delay greater than 30 minutes. No patient injuries were reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1643264-2020-00008 |
| MDR Report Key | 9540341 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-02 |
| Date of Report | 2020-02-07 |
| Date of Event | 2019-12-10 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-01-02 |
| 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 | HOLLY TOPPING |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123913905 |
| 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 | SYSTEM, LIGHT SOURCE, 500XL, ENGLISH |
| Generic Name | LIGHT SOURCE, FIBEROPTIC, ROUTINE |
| Product Code | FCW |
| Date Received | 2020-01-02 |
| Catalog Number | 72200580 |
| 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 | 2020-01-02 |