MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-29 for DISP FIRSTPASS STR PASSR SELF 22-4038 manufactured by Arthrocare Corp..
[113000174]
Foreign zip code: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[113000175]
It was reported that the shaft of the firstpass st broke away from the handle. There was a backup device available to complete the procedure and no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006524618-2018-00349 |
| MDR Report Key | 7651099 |
| Date Received | 2018-06-29 |
| Date of Report | 2018-08-21 |
| Date of Event | 2018-06-19 |
| Date Mfgr Received | 2018-08-17 |
| Date Added to Maude | 2018-06-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer G1 | ARTHROCARE CORP. |
| Manufacturer Street | 7000 W. WILLIAM CANNON |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78735 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DISP FIRSTPASS STR PASSR SELF |
| Generic Name | CLIP, TANTALUM, OPHTHALMIC |
| Product Code | OVN |
| Date Received | 2018-06-29 |
| Returned To Mfg | 2018-08-16 |
| Catalog Number | 22-4038 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ARTHROCARE CORP. |
| Manufacturer Address | 7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735 |
| Brand Name | DISP FIRSTPASS STR PASSR SELF |
| Generic Name | CLIP, TANTALUM, OPHTHALMIC |
| Product Code | HQW |
| Date Received | 2018-06-29 |
| Catalog Number | 22-4038 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROCARE CORP. |
| Manufacturer Address | 7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-29 |