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

Model Number	ACH4041-01
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the topaz wand was connected with controller and e7 and e8 alarm occurred.The malfunction was found during set up of achilles tendon surgery.No patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.Visual inspection of the device showed minimal erosion of the electrodes, the tip of the shaft was bent.The device was connected to a known good controller which displayed an "e7 error".The device was then connected to the known good controller using a bypass box, which revealed the device's ablate and saline performed as intended despite the bent tip.The complaint was verified as the device displayed an e7 error.The root cause was determined to be due to reuse of a single device.Factors, which may have contributed to the reported complaint include: (1) previous use (2) disconnecting the wand from the controller after power has been turned on.(3) an e-8 error will occur when a wand is connected before the generator is powered on.(4) incorrect power cycling of the controller can also have an effect on the wands life cycle.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: 10411943
• Report Number: 3006524618-2020-00643
• Device Sequence Number: 14239284
• Product Code: GEI
• UDI-Device Identifier: 00817470003574
• UDI-Public: 00817470003574
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020

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 Model Number: ACH4041-01
• Device Catalogue Number: ACH4041-01
• Device Lot Number: 2047039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 08/16/2020
• Supplement Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1