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	07/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee arthroscopy it was discovered the device's tip had fell inside the patient.There was a backup device available.No significant delay was reported.No injury was reported; however, the tip remained inside the patient.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.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 and smooth edges on the remaining electrode legs.There is also discoloration on the adhesive and scratch marks on the exposed shaft.There are no manufacturing abnormalities visually observed with the returned device.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 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.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.The instruction for use 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: 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: 8878351
• Report Number: 3006524618-2019-00379
• Device Sequence Number: 2047972
• Product Code: GEI
• UDI-Device Identifier: 00817470004908
• UDI-Public: 00817470004908
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K083306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2019

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: 04/03/2022
• Device Catalogue Number: ASH4830-01
• Device Lot Number: 2031542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1