MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-23 for ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE 7210424 manufactured by Smith & Nephew, Inc..
[100976922]
Patient Sequence No: 1, Text Type: N, H10
[100976923]
It was reported that the surgeon was unable to pass the loop inside the accupass. There was no back up available.
Patient Sequence No: 1, Text Type: D, B5
[122851942]
Examination was not possible, as the device has not been returned. The investigation could not draw any conclusions about the reported event without the return of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219602-2018-00256 |
| MDR Report Key | 7293925 |
| Date Received | 2018-02-23 |
| Date of Report | 2018-03-21 |
| Date of Event | 2018-01-29 |
| Date Mfgr Received | 2018-03-19 |
| Device Manufacturer Date | 2016-12-19 |
| Date Added to Maude | 2018-02-23 |
| 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 | 130 FORBES BOULEVARD |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE |
| Generic Name | TROUSERS, ANTI-SHOCK |
| Product Code | LHX |
| Date Received | 2018-02-23 |
| Model Number | 7210424 |
| Catalog Number | 7210424 |
| Lot Number | 50637272 |
| Device Expiration Date | 2019-12-19 |
| 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 | 130 FORBES BOULEVARD MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-23 |