MAUDE Adverse Event Report: ARTHROCARE CORP. SUPER TURBOVAC 90; SHOULDER PROBES - AR

Catalog Number EDASC4250-01

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2015

Event Type  malfunction  

Event Description

It was reported that during a shoulder procedure using a super turbovac 90 icw wand, the outer ring detached from the wand tip while inside the surgical site.The detached piece was removed and the procedure was completed successfully, however, the event caused a 30 minute surgical delay.There have been no reported patient complications.

Manufacturer Narrative

The complaint could not be verified nor could a definitive root cause be determined with confidence as the device was not returned for analysis.There was no information available to indicate what the total activation time was, set points used or whether a cannula or any other apparatus¿ were used during the procedure.Factors not associated with the manufacture or design of the device which could result in damage to the tip could be that the device came into abrupt contact with a hard (metallic) object, improper removal from an apparatus, and use at a higher than recommended set point or excessive force applied to tip can also lead to unintended.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SUPER TURBOVAC 90
• Type of Device: SHOULDER PROBES - AR
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon dr.; austin, TX 78735 ; 5123913900
• MDR Report Key: 5026249
• MDR Text Key: 24778787
• Report Number: 3006524618-2015-00502
• Device Sequence Number: 1
• Product Code: BWA
• Combination Product (y/n): N
• PMA/PMN Number: K033584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EDASC4250-01
• Device Lot Number: 1093354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2015
• 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 Age: 66 YR