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

Model Number ASHA4250-01

Device Problem Connection Problem (2900)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 10/14/2020

Event Type  Injury  

Event Description

It was reported that during the surgery after the console was turned on and the ambient super turbovac wand was connected it was not recognized by the controller, it was stated that the staff waited a few minutes to see if the wand was recognized but it was not.No patient injuries or significant delay was reported.Another smith and nephew device (ambient radio frequency tip) was used to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined.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 a isolated issue.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found that previous use or incorrect power cycling of the controller can result in wand failure.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.Factors that could have contributed to the reported event include: (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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: AMBIENT SUPER TURBOVAC 90 IFS
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10807265
• MDR Text Key: 215269593
• Report Number: 3006524618-2020-00964
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470000016
• UDI-Public: 00817470000016
• Combination Product (y/n): N
• PMA/PMN Number: K083306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2023
• Device Model Number: ASHA4250-01
• Device Catalogue Number: ASHA4250-01
• Device Lot Number: 2046959
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention