MAUDE Adverse Event Report: ARTHROCARE CORP. SUPER TURBOVAC 90 IFS; ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT-CONTROLLED, SINGLE USE

Catalog Number ASH4250-01

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/07/2015

Event Type  malfunction  

Event Description

It was reported that during a shoulder procedure using a super turbovac 90 ifs wand, after 7 minutes of activation the surgeon alleged that the plastic ring on the wand tip detached while in the surgical site.The surgeon was able to retrieve part of the plastic, but decided to abandon some debris in the tissue because it was hard to remove.There were no significant delays or patient complications reported as a result of this event.

Manufacturer Narrative

Visual evaluation showed moderate electrode wear with discoloration on the cap from activation.Adhesive was detached around the spacer with scratch marks present on the cap.There were also scratch and scuff marks on the black shrink tube from the tip to the handle of the device.The customer¿s complaint was visually verified and the root cause is most likely associated with coming into contact with a sharp or hard object, such as a cannula.It is possible that upon insertion or removal of the device, using a cannula, the tip inadvertently came into contact with the cannula boundaries, therefore causing the adhesive to become detached.The instructions for use outlines warnings and precautionary measures to adhere to during activation of the device.There are no indications to suggest the device did not meet product specifications upon release into distribution.

• Brand Name: SUPER TURBOVAC 90 IFS
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT-CONTROLLED, SINGLE USE
• 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
• MDR Report Key: 5159707
• MDR Text Key: 28948017
• Report Number: 3006524618-2015-00538
• Device Sequence Number: 1
• Product Code: JOS
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K090393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASH4250-01
• Device Lot Number: 1038272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2015
• 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