MAUDE Adverse Event Report: ARTHROCARE CORP. DISP FIRSTPASS STR PASSR SELF; PASSER

Model Number 22-4038

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2020

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, the firstpass was breaking up.The procedure was completed with a back up device with no delay or patient injury reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h6: the device reported, used in treatment, was not returned for evaluation.The relationship between the product and reported incident cannot be established.A review of manufacturing records for the reported lot number 2040221 found no non-conformances or anomalies during manufacturing process related to the reported event.The review of the complaint history for the associated complaint product found no similar events in the last three years for the involved lot.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: (1) excessive force.(2) tissue thickness.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.

• Brand Name: DISP FIRSTPASS STR PASSR SELF
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9714411
• MDR Text Key: 180028383
• Report Number: 3006524618-2020-00063
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2022
• Device Model Number: 22-4038
• Device Catalogue Number: 22-4038
• Device Lot Number: 2040221
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1