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 Information (3190)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, when the wand was plugged into the quantum controller, immediately alarmed stating "wand error".The wand could not be used and a different technique was used in order to complete the surgery.No other complications or significant delay were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Visual inspection of the device revealed that the device's shaft was bent, minimal erosion of the electrode tip, and a cut saline line.The device's resistance was measured to be 1.866 kohms.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 performed as intended.The saline line was tested using a syringe and performed as intended.The complaint was verified as the device displayed an e7 error.The root cause was determined to be reuse of a single use 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.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: 10754129
• Report Number: 3006524618-2020-00934
• Device Sequence Number: 19704597
• Product Code: GEI
• UDI-Device Identifier: 00817470003574
• UDI-Public: 00817470003574
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2022
• Device Model Number: ACH4041-01
• Device Catalogue Number: ACH4041-01
• Device Lot Number: 2035057
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention