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

Model Number	ASH4250-01
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during shoulder arthroscopy at the start of a case once plugged in, it started to alarm.After unplugging and re-plugging in, the wand still continued to alarm.No delay and a back up was available to complete the procedure.No other complications were 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, used in treatment, was returned for evaluation.There was a relationship found between the returned 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.A complaint history review concluded this was an isolated event.Visual inspection of the device showed minimal erosion of the electrode screen and some contamination of the tip.The device's resistance was measure to be 1.049 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 complaint was verified as the device performed as intended.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 there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 10624638
• Report Number: 3006524618-2020-00850
• Device Sequence Number: 11420127
• Product Code: GEI
• UDI-Device Identifier: 00817470006506
• UDI-Public: 00817470006506
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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: 02/16/2023
• Device Model Number: ASH4250-01
• Device Catalogue Number: ASH4250-01
• Device Lot Number: 2051396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 10/04/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1