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

Model Number	ASC4730-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a hip arthroscopy, the multivac 50 xl wand lost a metal bead inside the patient, which was then removed.The procedure was successfully completed without significant delay using a back-up device.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3, h6: the device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.A review of manufacturing records for the reported lot number found no non-conformances or anomalies during manufacturing process related to the reported event.A complaint history review found a related failure; this failure mode will be trended to assess for any necessary corrective actions.Visual inspection under magnification of the wand shows a detached electrode with contamination on the screen, and a evidence of moderate erosion on the screen.The device was plugged into a known good controller, which revealed that the ablate and coagulate functions of the device performed as intended.Suction performed as intended.The complaint was verified as the device indicates a missing electrode.The root cause could not be determined with certainty.Factors unrelated to the design or manufacture of the device which could have contributed to the complaint event includes: (1) extensive activation of the device (2) settings used during activation (3) mechanical displacement of tissue (4) using the device as a lever.There are no indications to suggest the device did not meet product specifications upon release into distribution.

• Brand Name: MULTIVAC 50 XL ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9826459
• Report Number: 3006524618-2020-00106
• Device Sequence Number: 1551342
• Product Code: GEI
• UDI-Device Identifier: 00817470006261
• UDI-Public: 00817470006261
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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: 08/03/2022
• Device Model Number: ASC4730-01
• Device Catalogue Number: ASC4730-01
• Device Lot Number: 2038010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1