MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-24 for DISP FIRSTPASS STR PASSR SELF 22-4038 manufactured by Arthrocare Corp..
[187909727]
It was reported that, during a shoulder arthroscopy, when the firstpass suture passer was fired, the product locked inside of the joint. After finally getting product out of joint it was noticed that the jaw was stuck in closed position and the needle was bent out of the side of the jaw, instead of firing up through the self-capture mechanism. A replacement product was on hand. It is unknown if surgery was delayed as consequence of the allegation. There was a slight damage to the patient tissue. 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 | 3006524618-2020-00122 |
| MDR Report Key | 9875474 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-10-08 |
| Date Added to Maude | 2020-03-24 |
| 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 | 2020-03-24 |
| Returned To Mfg | 2020-03-10 |
| Model Number | 22-4038 |
| Catalog Number | 22-4038 |
| Lot Number | 2042053 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2020-03-24 |