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 2020-03-03 for SPIDER 2 TENET 7615 72203299 manufactured by Smith & Nephew, Inc..
[181807400]
H10smith & nephew is submitting this report pursuant to the provisions of 21 c. F. R. Part 803. This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
Patient Sequence No: 1, Text Type: N, H10
[181807401]
It was reported that, during a shoulder case, the arm of the spider 2 tenet lost pressure. In consequence, the arm exhibited a loss of traction and could not hold in position. The procedure was completed without delay using the same faulty device. No patient injuries 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 | 1643264-2020-00112 |
| MDR Report Key | 9779947 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-03-24 |
| Date Added to Maude | 2020-03-03 |
| 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 | SPIDER 2 TENET 7615 |
| Generic Name | TABLE, OPERATING-ROOM, ELECTRICAL |
| Product Code | GDC |
| Date Received | 2020-03-03 |
| Returned To Mfg | 2020-02-20 |
| Catalog Number | 72203299 |
| 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 | 2020-03-03 |