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

Model Number ACH4041-01

Device Problem Protective Measures Problem (3015)

Patient Problem No Information (3190)

Event Date 09/22/2020

Event Type  malfunction  

Event 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.

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
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10754129
• MDR Text Key: 213618034
• Report Number: 3006524618-2020-00934
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470003574
• UDI-Public: 00817470003574
• Combination Product (y/n): N
• PMA/PMN Number: K140521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 11/11/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention