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

Model Number	ASC1336-01
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip arthroscopy, the device was oxidized inside the box, the doctor decided to use it in the patient because he was anesthetized and no other device was available.The procedure was completed with the same device with no delay or patient injury reported.
Additional Manufacturer Narrative
H10.H3, h6: the turbovac 90 xl icw, used in treatment, was returned for evaluation.A relationship between the device and reported incident was established.From the information provided, ¿during a hip arthroscopy, the device was oxidized inside the box, the doctor decided to use it in the patient because he was anesthetized and no other device was available.¿ device history review/batch record review shows no ncrs or deviations associated to the lot number and relevant to the complaint.The review of the complaint history for the associated complaint product found no similar events in the last three years for the involved lot.Visual inspection under magnification shows moderate wear and fibers on the electrodes.The shaft is bent and shows rusted spots.The length of the largest rusted spot on the surface of the device shaft is 3.49mm.During functional evaluation the device was plugged to a q2 controller and activated in saline solution at default and max.Settings.The device performed as intended.The complaint has been verified as the device shaft is rusted.A manufacturing assessment was completed and concluded there is no workmanship issue as the records show the device passed all control points before it was released to distribution.Factors that could contribute to this failure include storage conditions such as temperature and humidity.No containment or corrective actions are recommended at this time.

• 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: 9102252
• Report Number: 3006524618-2019-00479
• Device Sequence Number: 14185096
• Product Code: GEI
• UDI-Device Identifier: 00817470006520
• UDI-Public: 00817470006520
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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 Expiration Date: 10/17/2021
• Device Model Number: ASC1336-01
• Device Catalogue Number: ASC1336-01
• Device Lot Number: 2022308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 09/22/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR