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	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a right hip arthroscopy procedure, a metal part at the end of the electrode detached while inserted into the patient.The tip has been found and was recovered.The procedure was extended by 1 hour and 30 minutes and no report of procedure cancellations were received.No patient injuries were reported.
Additional Manufacturer Narrative
The returned device, intended for use in treatment, was returned 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 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.Excessive wear of screen/electrodes result from vigorous use against bony surfaces; the wand is supplied sterile, and is for single use only.Do not clean, resterilize, or reuse the wand, as this may damage or compromise the performance resulting in product malfunction, failure, or patient injury.Cleaning, resterilization, or reuse of the wand may also expose the patient to the risk of transmitting infections diseases or results in irregular wear leading to malfunction.There were no indications that would suggest that 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: 9134473
• Report Number: 3006524618-2019-00494
• Device Sequence Number: 11218890
• 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: 02/23/2022
• Device Catalogue Number: ASH4830-01
• Device Lot Number: 2028188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 09/30/2019
• 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