MAUDE Adverse Event Report: ARTHROCARE CORPORATION AMBIENT SUPER MULTIVAC 50 WITH INTEGRATED FING; ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND

Model Number ASHA4830-01

Device Problems Device Or Device Fragments Location Unknown (2590); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/29/2015

Event Type  malfunction  

Event Description

It was reported that during a knee procedure using an ambient super multivac 50 ifs wand, a piece of the wand's tip detached from the wand while inside the surgical site.The surgeon was unable to locate the foreign body and is unsure if it was removed via suction or remains in the patient.There have been no patient complication reported as a result of this event.

Manufacturer Narrative

The customer's complaint that the tip detached was able to be verified; however, physical evidence suggests that it was user induced.Visual inspection under magnification shows extensive damage to the tip of the wand.The electrode screen has been completely detached and the electrode legs show jagged edges consistent with fracture due to mechanical force.It is also evident that the device came into abrupt contact with a hard (metallic) object or came into contact with the boundaries of a cannula which caused the screen to be detached, electrodes to exhibit jagged edges and adhesive to detach on the spacer; hence, the root cause is the customer did not use proper technique as outlined in the ifu.The ifu states: the wand is designed for ablation and/or coagulation only, and not for mechanical displacement of tissue through applied force.Do not use the wand as a lever to enlarge a surgical site or gain access to tissue as this may result in a bent or detached electrode, damage to device and/or a cracked spacer leading to patient injury.Do not contact metal objects while activating the wand as damage to the tip and/or shaft insulation may occur resulting in device malfunction or patient injury.There are no findings that would indicate the wand did not meet specifications when delivered to the customer.

• Brand Name: AMBIENT SUPER MULTIVAC 50 WITH INTEGRATED FING
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND
• Manufacturer (Section D): ARTHROCARE CORPORATION; austin TX
• Manufacturer (Section G): ARTHROCARE COSTA RICA; la aurora, heredia ; CS
• Manufacturer Contact: wendy laird ; 7000 w william cannon dr; austin, TX 78735-0000 ; 5123585933
• MDR Report Key: 4615737
• MDR Text Key: 21766797
• Report Number: 3006524618-2015-00036
• Device Sequence Number: 1
• Product Code: GEI
• 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,user facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2015
• Device Model Number: ASHA4830-01
• Device Lot Number: 1031267
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/26/2015
• Date Manufacturer Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2013
• 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