MAUDE Adverse Event Report: ARTHROCARE CORP. AMBIENT SUPER MULTIVAC 50 IFS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number ASHA4830-01

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Device Or Device Fragments Location Unknown (2590)

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

Event Date 04/05/2018

Event Type  malfunction  

Event Description

It was reported that the metal tip of the wand fell off during a hip arthroscopy and was believed to have fallen off in the patient, but the surgeon/xray was unable to locate it.No significant delay or patient injury reported.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection under magnification shows the electrodes have been detached with jagged edges on the remaining electrode legs.There is also discoloration on the adhesive and scuff marks on the spacer.There is a significant amount of scratch marks on the exposed shaft and black shrink tube near the tip of the wand.There are no manufacturing abnormalities visually observed with the returned device.The wand was connected to a compatible controller and registered an e-7 error.The error was by-passed and the wand was activated in saline solution at the default and max settings on the controller and plasma was created on the remaining electrodes.The suction line was tested and performed as intended.The complaint has been visually verified and the root cause was more than likely associated with the device potentially coming into contact with a metal object such as a cannula.Other factors that could have led to tip detachment includes: mechanical displacement of tissue through applied force or using the device as a lever to enlarge a surgical site or gain access to tissue.

• Brand Name: AMBIENT SUPER MULTIVAC 50 IFS
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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 west william cannon drive; austin, TX 78735
• MDR Report Key: 7481793
• MDR Text Key: 107476371
• Report Number: 3006524618-2018-00219
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASHA4830-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2018
• 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
• Patient Age: 33 YR