MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-12-26 for DISP FIRSTPASS STR PASSR SELF 22-4038 manufactured by Arthrocare Corp..
[177948670]
It was reported that during a procedure the metal teeth were broken, all pieces were removed with graspers from the patient. The procedure was successfully completed without delay using a back-up device. No patient injury 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
[189066891]
The device reported, used in treatment, was not returned for evaluation. The relationship between the product and reported incident cannot be established. A dhr/batch record review for lot finding no discrepancies from released and operating procedures nor conditions that could contribute to the event. Lot history review for the last 3 years shows 0 (zero) complaints associated to lot number and relevant to the complaint. Without the reported product a fully visual and functional evaluation cannot be performed and customer? S complaint cannot be confirmed. An exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: excessive force, tissue thickness, damage of the tip between passes. No containment or corrective actions are recommended at this time. There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006524618-2019-00619 |
| MDR Report Key | 9520518 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-12-26 |
| Date of Report | 2020-02-19 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2019-05-08 |
| Date Added to Maude | 2019-12-26 |
| 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 | 2019-12-26 |
| Model Number | 22-4038 |
| Catalog Number | 22-4038 |
| Lot Number | 2038597 |
| 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 | 2019-12-26 |