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

Catalog Number	ASH4830-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip arthroscopy the metal part at the end of the electrode detached.It is unknown if there was a backup available and how the issue was resolved.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The product, intended to be used for treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined.Visual inspection and functional testing could not be performed since the device was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.Potential factors unrelated to the manufacturing or design of the device which could have contributed to the reported event include: 1.Check the wand tip periodically to ensure the electrode is intact and the wand is functioning as designed.2.If the electrode is not intact, discontinue use and check the joint cavity by appropriate means.3.The wand/controller should be inspected prior to, and periodically during, surgery for any damage as this could adversely impact performance, safety and clinical outcome.4.Do not use if damaged or malfunctioning.There are no indications to suggest the device did not meet product specifications upon release into distribution.Complaint history search revealed no additional complaints for this production lot.

• 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: 9160374
• Report Number: 3006524618-2019-00502
• Device Sequence Number: 11374904
• Product Code: GEI
• UDI-Device Identifier: 00817470004908
• UDI-Public: 00817470004908
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019

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: 08/16/2021
• Device Catalogue Number: ASH4830-01
• Device Lot Number: 2019180
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 10/06/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1