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

Model Number	ASH4830-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The super multivac 50 ifs wand, used in treatment, was returned for evaluation.A relationship between the device and reported incident was established.From the information provided, ¿during a knee arthroscopy, the super multivac 50 was found to be broken." a review of manufacturing records for the reported lot number 2042993 found no non-conformance's or anomalies during manufacturing process related to the reported event.The review of the complaint history for the associated complaint product found no similar events in the last three years for the involved lot.Device visual evaluation shows the flat screen electrode is detached and not available.No manufacturing discrepancies observed.During functional evaluation the fuse resistance was measured and registered 1,505 ohms prior to activation and this indicated a blown fuse.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 electrode.The suction line was tested and performed as intended.The complaint has been visually verified and the root cause is 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.No containment or corrective actions are recommended at this time.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that, during a knee arthroscopy, the super multivac 50 was found to be broken.There was a backup device available.No delay or patient injury was reported.Results of the investigation have concluded that the wand's flat-screen electrode is detached and not available which indicates an actual fragmentation of the device and this makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• 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: 9841821
• Report Number: 3006524618-2020-00113
• Device Sequence Number: 742909
• Product Code: GEI
• UDI-Device Identifier: 00817470004908
• UDI-Public: 00817470004908
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 03/17/2020

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: 10/31/2022
• Device Model Number: ASH4830-01
• Device Catalogue Number: ASH4830-01
• Device Lot Number: 2042993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1