MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-12-02 for LENS INTEGRATED SYSTEM WIFI VERSION 72204354 manufactured by Smith & Nephew, Inc..
[168687973]
It was reported that, during a shoulder arthroscopy, the lens integrated system did not hold the wifi signal. It is unknown how the procedure was completed. The surgery was delayed for more than 30 min. The patient was not harmed. 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 | 1643264-2019-00852 |
| MDR Report Key | 9396336 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-12-02 |
| Date of Report | 2020-03-09 |
| Date of Event | 2019-11-08 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2019-12-02 |
| 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 | LENS INTEGRATED SYSTEM WIFI VERSION |
| Generic Name | TABLE, OPERATING-ROOM, ELECTRICAL |
| Product Code | GDC |
| Date Received | 2019-12-02 |
| Returned To Mfg | 2020-01-14 |
| Model Number | 72204354 |
| Catalog Number | 72204354 |
| 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 | 2019-12-02 |