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

Catalog Number ASC4830-01

Device Problems Break (1069); Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

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

Event Date 10/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that part of the metal face of the wand came off during a hip arthroscopy.The surgeon attempted to visualize the broken piece using x-ray guidance but was unable to locate or retrieve it.No patient injury or other complications were 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 partial detachment of the electrodes with jagged edges on the remaining electrode leg.There is a significant amount of discoloration on the adhesive around the spacer.There is scratch marks present on the exposed shaft near the tip and the shaft has been bent midway from the tip and handle of the device.The cable has been severed prior to being received for evaluation; therefore, a functional test could not be conducted.There are no manufacturing abnormalities visually observed with the returned device.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.The instruction for use (¿ifu¿) outlines warnings and precautionary measures to adhere to during activation of the device.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SUPER MULTIVAC 50 ICW
• 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 w. william cannon; austin, TX 78735 ; 5123585706
• MDR Report Key: 6082656
• MDR Text Key: 59797977
• Report Number: 3006524618-2016-00293
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K033584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASC4830-01
• Device Lot Number: 1148261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2016
• 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