MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-05 for FIRSTPASS MINI STRAIGHT 72290128 manufactured by Arthrocare Corp..
[182327034]
It was reported that, during a meniscus repair surgery, the specialist used the clamp several times on patient without success, it was thought it was associated with poor quality tissue. In spite of it, the specialist tried to pass a few points again to correct the defect, but he did not succeed. After this, it was noticed that the clamp did not have the plate (suture trap). The knee was checked and it was evidenced that remains of plaque were completely removed. The procedure was successfully completed without significant delay using a back-up 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 | 3006524618-2020-00092 |
| MDR Report Key | 9795604 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-05 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-03-31 |
| Device Manufacturer Date | 2019-06-15 |
| Date Added to Maude | 2020-03-05 |
| 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 | 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 | FIRSTPASS MINI STRAIGHT |
| Generic Name | ACCESSORIES,ARTHROSCOPIC |
| Product Code | NBH |
| Date Received | 2020-03-05 |
| Model Number | 72290128 |
| Catalog Number | 72290128 |
| Lot Number | 2035028 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-05 |