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

Catalog Number ASC4250-01

Device Problems Failure to Cut (2587); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/26/2018

Event Type  malfunction  

Event Description

It was reported that the surgeon unable to cut or coag (video attached).This is se second probe reported.No back up was available.

Manufacturer Narrative

The returned device, intended for use in treatment, was returned as an mdr for evaluation.There was no relationship found between the returned device and the reported incident.Visual inspection under magnification of the wand shows minimal electrodes/screen wear with contamination/discoloration and scratch/scuff marks on the spacer and cap.The insulation on the shaft is in its original condition.There are no manufacturing abnormalities visually observed with the returned wand.The returned device was plugged into a quantum2 controller was activated on ablate and coag settings and produced plasma at ablate and coag settings as intended.The suction line was tested and performed as intended.The device was returned with a closed roller clamp on the suction line which probably was the cause of the non-functional device during use.The complaint was not verified and the root cause not could not be determined with confidence.It is possible that the closed roller clamp on the suction line is probably the cause of the non-functional device during use.A closed roller clamp is decreasing the functionality of the device.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Device returned for evaluation.Device evaluated by the manufacturer.Evaluation codes updated.

Event Description

It was reported that the surgeon was unable to cut or coag using the device.No backup was available and no significant delay was reported.

• 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: 7450755
• MDR Text Key: 106854505
• Report Number: 3006524618-2018-00202
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K033584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2020
• Device Catalogue Number: ASC4250-01
• Device Lot Number: 2007026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 05/31/2018
• Supplement Dates FDA Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1