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

Model Number	ASH4250-01
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during setup when the nurse plugged the probe into the generator, it was not functioning.Another probe of the same reference was used to complete the procedure.It is unknown if there was a delay, no patient injuries reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.There was a relationship found between the device and the reported incident.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.Visual inspection under magnification of the wand shows minimal electrode and screen erosion with discoloration/contamination and scratch/scuff marks on the spacer and cap.There are no manufacturing abnormalities visually observed with the returned wand.The device was returned with a cut junction cable hence it could not be functional tested; the suction line was tested and was clogged by dried parts of tissue; a back flush cleaned the line and the suction line is working as intended; the complaint was verified.Factors unrelated to the design or manufacture of the device that could have contributed to the complaint event includes: (1) that the suction line became disconnected, suction pressure may have not been enough to excavate blood and tissue, or (2) there was an attempt to excavate large ablated tissue remnants.These factors can cause the tip to clog; therefore, decreasing the functionality of the wand.There are no indications to suggest the device did not meet product specifications upon release into distribution.No containment or corrective actions are recommended at this time.

• Brand Name: SUPER TURBOVAC 90 IFS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10393150
• Report Number: 3006524618-2020-00627
• Device Sequence Number: 19306917
• Product Code: GEI
• UDI-Device Identifier: 00817470006506
• UDI-Public: 00817470006506
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083306
• 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): 09/14/2020

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: 08/30/2022
• Device Model Number: ASH4250-01
• Device Catalogue Number: ASH4250-01
• Device Lot Number: 2039769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1