MAUDE Adverse Event Report: ARTHROCARE CORP. AMBIENT SUPER MULTIVAC 50 IFS; KNEE PROBES - ARTC

Catalog Number EDASHA4830-01

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

Patient Problem Foreign Body In Patient (2687)

Event Date 08/04/2015

Event Type  malfunction  

Event Description

It was reported that during a procedure using an ambient super multivac 50 wand, the electrode detached from the wand's tip while inside of the surgical site.The site was x-rayed, however the detached tip could not be located.The procedure was ultimately completed using a back up ambient super multivac 50 wand.There were no significant delays or patient complications reported as a result of this event.

Manufacturer Narrative

The device used for treatment was returned for visual and functional evaluation.The customer¿s complaint has been visually verified; however, the physical evidence would suggest the device had reached its end of useful life as can be seen by the rounded edges present on the remaining electrodes.The root cause for this event is expected wear and tear of the device as the failure is consistent with normal wear of the electrodes and is dependent on factors that can accelerate the wear of electrodes, such as using set points higher than the default settings or using the wand for an extended period of time.The ifu contains instructions on obtaining the maximum effect such as, ¿ambient super multivac 50 devices are not designed for prolonged ablation.Electrodes wear under use and the rate of wear is dependent on variables that cannot be replicated in all cases.Factors of electrode wear include, but are not limited to, rate of ablation, power settings, prolonged use against dense or bony surfaces, suction rate, and fluid management.¿ a device history review confirmed that no abnormalities were reported with this product during manufacture.

• Brand Name: AMBIENT SUPER MULTIVAC 50 IFS
• Type of Device: KNEE PROBES - ARTC
• 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 ; 5123585933
• MDR Report Key: 5051300
• MDR Text Key: 25508220
• Report Number: 3006524618-2015-00503
• 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: 08/10/2015

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: Health Professional
• Device Catalogue Number: EDASHA4830-01
• Device Lot Number: 1106026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2015
• 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