MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2019-10-15 for DISP FIRSTPASS STR PASSR SELF 22-4038 manufactured by Arthrocare Corp..
[162437931]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[162437932]
It was reported that during the surgery the jaw of the firstpass jammed shut inside the shoulder while trying to pass tape through the tendon. The black handle of the jaw, including the ratchet, was stuck all the way in and would not release. Eventually, by pulling the black handle with significant force the jaw was released and the device removed from the patient. The needle was inspected as intact. The device break inside the patient and the pieces were retrieved. A backup device was available to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006524618-2019-00515 |
| MDR Report Key | 9195148 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2019-10-15 |
| Date of Report | 2019-10-15 |
| Date of Event | 2019-09-24 |
| Date Mfgr Received | 2019-09-24 |
| Device Manufacturer Date | 2018-08-20 |
| Date Added to Maude | 2019-10-15 |
| 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 | 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 | 3 |
| Brand Name | DISP FIRSTPASS STR PASSR SELF |
| Generic Name | PASSER |
| Product Code | HWQ |
| Date Received | 2019-10-15 |
| Catalog Number | 22-4038 |
| Lot Number | 2018932 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-10-15 |