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

Model Number	ASH4830-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that during the surgery the metal part of the super multivac 50 electrode detached its self from the top.A backup device was available to complete the procedure with no delay.
Event or Problem Description
It was reported that during the surgery the metal part of the super multivac 50 electrode detached its self from the top.All the pieces were removed.A backup device was available to complete the procedure with no significant delay and no patient injuries.
Additional Manufacturer Narrative
The returned device, intended for use in treatment, was returned as an mdr for evaluation.There was a relationship between the returned device and the reported event.Visual inspection under magnification shows a detached electrode.Most of the screen is detached and not returned with the device.There are no manufacturing abnormalities visually observed with the returned device.The returned device had no functionality and registered an error e-7 when plugged into a known good quantum controller.The error was by-passed and the device is producing plasma on ablate/coag settings on the remaining parts of the electrode.The suction line was tested and performed as specified.The complaint was verified, however the root cause could not be determined with certainty since the device was comprehensively used.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SUPER MULTIVAC 50 IFS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• MDR Report Key: 7711153
• Report Number: 3006524618-2018-00361
• Device Sequence Number: 1107277
• Product Code: GEI
• UDI-Device Identifier: 00817470004908
• UDI-Public: (01)00817470004908(17)201021(10)2007505
• Combination Product (Y/N): N
• PMA/510(K) Number: K083306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2018

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: 10/21/2020
• Device Model Number: ASH4830-01
• Device Catalogue Number: ASH4830-01
• Device Lot Number: 2007505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 09/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1