MAUDE Adverse Event Report: ARTHROCARE CORPORATION AMBIENT SUPER TURBOVAC 90 WITH INTEGRATED FING; ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND

Catalog Number ASHA4250-01

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 02/26/2015

Event Type  malfunction  

Event Description

It was reported that during a hip procedure using an ambient super turbovac 90 ifs wand, the electrode balls from the wand tip detached while inside the surgical site.The detached piece was unable to be retrieved from the patient, but otherwise the procedure was completed successfully without delay.There have been no patient complications reported as a result of this event.

• Brand Name: AMBIENT SUPER TURBOVAC 90 WITH INTEGRATED FING
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND
• Manufacturer (Section D): ARTHROCARE CORPORATION; austin TX
• Manufacturer (Section G): ARTHROCARE COSTA RICA; la aurora heredia ; CS
• Manufacturer Contact: wendy laird ; 7000 w william cannon dr; bldg 1; austin, TX 78735 ; 5123585933
• MDR Report Key: 4690013
• MDR Text Key: 5650577
• Report Number: 3006524618-2015-00047
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K083306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2017
• Device Catalogue Number: ASHA4250-01
• Device Lot Number: 1080176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2014
• 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