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

Model Number	ACH4041-01
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that during a release of plantar fascia procedure an e7 error message occurred when a new wand was opened and connected to the controller.Backup device was available to complete the procedure.A delay greater than 30 minutes was reported with no patient injuries.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.A review of the customer provided images shows a controller with e7 error and the packaging confirming part number and lot number.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) previous use (2) disconnecting the wand from the controller after power has been turned on.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection of the returned instrument shows no manufacturing abnormalities.No visual issues were observed.Product was out of the original packaging.No packaging returned.A functional evaluation revealed the controller generated an e7 error when the wand was connected.When used with a bypass box the device generated plasma as intended.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.A review of the customer provided images shows a controller with e7 error and the packaging confirming part number ach4041-01 and lot number 2060010.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) previous use (2) disconnecting the wand from the controller after power has been turned on.No containment or corrective actions are recommended at this time.

• Brand Name: TOPAZ EZ IFS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12298129
• Report Number: 3006524618-2021-00822
• Device Sequence Number: 19867632
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2021

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: 08/21/2023
• Device Model Number: ACH4041-01
• Device Catalogue Number: ACH4041-01
• Device Lot Number: 2060010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 09/03/2021; 11/09/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 09/06/2021; 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male