MAUDE Adverse Event Report: ARTHROCARE CORPORATION SUPER TURBOVAC 90 ICW; ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND

Catalog Number ASC4250-01

Device Problems Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/08/2014

Event Type  malfunction  

Event Description

It was reported via a voluntary medwatch report that during a shoulder procedure using a super turbovac 90 icw wand, the electrode from the wand tip allegedly detached after 15 minutes of use.The surgical site was searched and flushed, however no foreign debris was found.There were no further patient complications reported as a result of this event.

• Brand Name: SUPER TURBOVAC 90 ICW
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND
• Manufacturer (Section D): ARTHROCARE CORPORATION; austin TX
• Manufacturer Contact: wendy laird ; 7000 w william cannon dr; bldg. 1; austin, TX 78735 ; 5123585933
• MDR Report Key: 4104680
• MDR Text Key: 4700468
• Report Number: 3006524618-2014-00272
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASC4250-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 51 YR
• Patient Weight: 99