MAUDE Adverse Event Report: ARTHROCARE CORP. AMBIENT SUPER TURBOVAC 90 IFS; SHOULDER PROBES

Catalog Number EDASHA4250-01

Device Problems Metal Shedding Debris (1804); Device Or Device Fragments Location Unknown (2590)

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

Event Date 08/12/2015

Event Type  malfunction  

Event Description

It was reported that during a procedure using an ambient super turbovac wand, a metallic fragment flaked off of the wand and fell into the joint.It could not be confirmed if the fragment was retrieved or left inside the patient.No further details have been provided regarding this event.

Manufacturer Narrative

Evaluation was not possible, as the device has not been returned.Due to this fact we are unable to determine what may have caused the user to experience the reported incident.A device history review confirmed that no abnormalities were reported with this product during manufacture.

• Brand Name: AMBIENT SUPER TURBOVAC 90 IFS
• Type of Device: SHOULDER PROBES
• 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: 5051814
• MDR Text Key: 25504449
• Report Number: 3006524618-2015-00506
• Device Sequence Number: 1
• Product Code: BWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: EDASHA4250-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1