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

Model Number	ASH4830-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the face plate fell into the patient.A backup device was available to complete the procedure with no major delay or patient injuries.It is unknown if plate was removed from patient as no information has been received from reporter.
Additional Manufacturer Narrative
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 top.Also, discoloration on the adhesive and scratch marks on the exposed shaft and black shrink tube near the tip.No manufacturing abnormalities visually observed with the returned device.The wand was connected 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 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 "trougth" an user error.Other factors could include: 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: SUPER MULTIVAC 50 IFS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7443891
• Report Number: 3006524618-2018-00196
• Device Sequence Number: 16186214
• Product Code: GEI
• UDI-Device Identifier: 00817470004908
• UDI-Public: (01)00817470004908(17)190228(10)1140415
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K083306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: ASH4830-01
• Device Catalogue Number: ASH4830-01
• Device Lot Number: 1140415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1