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

Catalog Number ASC4730-01

Device Problems Bent (1059); Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

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

Event Date 09/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported a multivac 50 xl wand was discovered to have a ball electrode missing and a bent electrode screen.It is unknown whether the piece fell off outside the patient on entry or inside during use.X-rays were taken during the procedure, however, the part could not be located.The patient was of good health and showed normal recovery from the procedure.

Manufacturer Narrative

Visual inspection under magnification shows the electrodes have been partially detached with jagged edges on the remaining electrode legs as well as the screen has been raised up from the spacer.There is a significant amount of scratch marks on the shaft and the spacer which are consistent with coming into contact with another metallic object.There are no manufacturing abnormalities visually observed with the returned device.The wand was connected to a compatible controller and activated in saline solution at the default and max settings on the controller and despite partial detachment of the electrode; 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.It is also possible that mechanical displacement of tissue through applied force or using the device as a lever to enlarge a surgical site or gain access to tissue can also cause this type of failure.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: MULTIVAC 50 XL 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 dr.; austin, TX 78735 ; 5123913900
• MDR Report Key: 5108007
• MDR Text Key: 27004517
• Report Number: 3006524618-2015-00521
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K033584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: ASC4730-01
• Device Lot Number: 1099330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2015
• 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
• Patient Outcome(s): Other