MAUDE Adverse Event Report: ARTHROCARE CORPORATION SUPER TURBOVAC 90 WITH INTEGRATED CABLE; ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT

Catalog Number ASC4250-01

Device Problems Device Or Device Fragments Location Unknown (2590); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/12/2015

Event Type  malfunction  

Event Description

It was reported that during a hip procedure using a super turbovac 90 icw wand, the electrode ball detached from the wand tip while in the joint.The surgeon was able to remove the ball from the joint space, but lost it in the soft tissue.The surgeon is unsure if it remains in the patient or if it was removed with suction; either way the surgeon was not concerned since it was out of the joint space.There were no significant delays and no patient complications have been reported as a result of this event.

Manufacturer Narrative

Visual inspection under magnification shows the bottom left electrode has been completely detached with jagged edges in conjunction with scratch marks present on the spacer as well as the cap.Evidence in the form of scratches and an electrode wire fracture surface suggest the side of the distal electrode tip came into abrupt contact with another hard or metallic object causing the electrode ball fracture and becoming detached.The remaining electrodes and screen show minimal wear with dried tissue present.There are no manufacturing abnormalities visually observed with the remaining components of the returned wand.The cable line was cut prior to being received for evaluation; however, due to the nature of the reported event, a functional test was not required.Physical evidence suggests that the returned device and the reported incident are more closely attributable to being used inappropriately and caused by mechanical force applied to the tip.Evaluation of the devices ifu found no reason for any corrective action.No remedial, corrective or preventive actions were found to be required, as no manufacturing, material or design issues were identified.

• Brand Name: SUPER TURBOVAC 90 WITH INTEGRATED CABLE
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT
• Manufacturer (Section D): ARTHROCARE CORPORATION; austin TX
• Manufacturer (Section G): ARTHROCARE COSTA RICA; la aurora ; CS
• Manufacturer Contact: wendy laird ; 7000 w william cannon dr; bldg 1; austin, TX 78735 ; 5123585933
• MDR Report Key: 4507722
• MDR Text Key: 5530942
• Report Number: 3006524618-2015-00018
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: ASC4250-01
• Device Lot Number: 1082736
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other