MAUDE Adverse Event Report: ARTHROCARE CORP. TOPAZ EZ IFS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	ACH4041-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the wand fell off.Incident occurred before the procedure; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: the device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.A review of manufacturing records for the reported lot number found no non-conformances or anomalies during manufacturing process related to the reported event.A complaint history review found no related failures.Visual inspection of the device showed a complete detachment of the electrodes and some discoloration of the tip.The device was connected to a known good controller, which revealed that while the device's tip was detached, the wand was able to electrically activate with no issues.Saline line performed as intended.Potential factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: 1) using the wand above default output settings, there by causing the electrode to detach.2) pressing the tip against hard or bony surfaces, there by causing the electrode to detach.No containment or corrective actions are recommended at this time.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: TOPAZ EZ IFS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10136072
• Report Number: 3006524618-2020-00348
• Device Sequence Number: 14216460
• Product Code: GEI
• UDI-Device Identifier: 00817470003574
• UDI-Public: 817470003574
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K140521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2023
• Device Catalogue Number: ACH4041-01
• Device Lot Number: 2049189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1