MAUDE Adverse Event Report: ARTHROCARE CORP. TURBOVAC 90 XL ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ASC1336-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient initials: (b)(6).
Event or Problem Description
It was reported that it was visualized on the monitor that the plate and the active electrodes were detached;.Doctor completed the procedure and the element that had been detached was removed.No patient injury was reported.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection under magnification shows the screen has been detached with jagged edges on the right electrodes.There are scuff marks present around the spacer as well as a significant amount of scratch marks present on the cap.There are no manufacturing abnormalities visually observed with the returned device.The wand was connected to a compatible controller and activated in saline solution at the default and max settings on the controller and despite detachment of the screen; plasma was created on the remaining electrodes.The suction line was tested and performed as intended.The complaint has been visually verified and the root cause was more than likely associated with the device coming into contact with a metal object such as a cannula.Other factors that could contribute to the detached screen and jagged electrodes include: mechanical displacement of tissue through applied force or using the device as a lever to enlarge a surgical site or gain access to tissue.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: TURBOVAC 90 XL ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7547001
• Report Number: 3006524618-2018-00278
• Device Sequence Number: 178937
• Product Code: GEI
• UDI-Device Identifier: 00817470006520
• UDI-Public: (01)00817470006520(17)191231(10)1180417
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018

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: 12/31/2019
• Device Model Number: ASC1336-01
• Device Catalogue Number: ASC1336-01
• Device Lot Number: 1180417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 05/26/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 60