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

Model Number ASC4250-01

Device Problem Failure to Deliver Energy (1211)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2020

Event Type  Injury  

Event Description

It was reported that, during an arthroscopy, the super turbovac could not be activated as intended, the power was weak to ablate tissue.The procedure was completed with a shaver system.No delay or further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Internal complaint reference (b)(4).H10 h3, h6: the device, used in treatment, was returned for evaluation.There was no 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 issue.A review of the instructions for use found statements related to output settings.A review of risk management files found that the reported failure was documented appropriately.Visual inspection of the device showed minimal erosion of the screen/electrodes and some discoloration of the spacer.The device was connected to a known good controller and the wand was tested at default and maximum settings, which revealed that the device performed as intended.The suction line performed as intended.The complaint was not verified and a root cause could not be determined as the device performed as intended.Factors, which may have contributed to the reported complaint include: 1) the device may have been used below default settings.2) there may have been an issue with one of the concomitant devices in use at the time of this complaint event.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SUPER TURBOVAC 90 ICW
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10808159
• MDR Text Key: 215270041
• Report Number: 3006524618-2020-00967
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470006421
• UDI-Public: 00817470006421
• Combination Product (y/n): N
• PMA/PMN Number: K033584
• 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: 12/14/2020

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 Model Number: ASC4250-01
• Device Catalogue Number: ASC4250-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention