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 2020-03-13 for SVCE REPL SPIDER 2 TENET 7615 72203299S manufactured by Smith & Nephew, Inc..
[183323726]
It was reported that during a shoulder arthroscopy the spider was stuck in one position, device got hot. After the procedure the spider was checked and the battery was all burned out. The procedure was successfully completed without delay using a back-up device. No patient injury or other complications 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 | 1643264-2020-00136 |
| MDR Report Key | 9830953 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-13 |
| 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 | 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 | SVCE REPL SPIDER 2 TENET 7615 |
| Generic Name | TABLE, OPERATING-ROOM, ELECTRICAL |
| Product Code | GDC |
| Date Received | 2020-03-13 |
| Catalog Number | 72203299S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-13 |