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

Model Number	ASH4250-01
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the wand did not connect; the rf unit did not recognize the wand.It is unknown whether the event happened during surgery and if there was patient involvement and if there was a back-up device available or if there was a delay.No further details were provided.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.A review of the device history records 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 and functional testing could not be performed since the device was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Potential factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: v.(1) previous use (2) disconnecting the wand from the controller after power has been turned on.(3) an issue with one of the concomitant devices in use at the time of this complaint event.There are no indications to suggest 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: 10257330
• Report Number: 3006524618-2020-00461
• Device Sequence Number: 3458484
• Product Code: GEI
• UDI-Device Identifier: 00817470006506
• UDI-Public: 00817470006506
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K083306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2020

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 Model Number: ASH4250-01
• Device Catalogue Number: ASH4250-01
• Device Lot Number: 2037839
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/24/2019
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1