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

Model Number	ASC4730-01
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a hip scope, when the multivac wand was connected to the controller, nothing would happen.The settings could not be manually changed and the display of the controller said 0 for coag and ablate.The procedure was successfully completed without delay using a different type of wand(ambient hipvac 50).No 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: h2, h6.The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.A review of the instructions for use found please read the controller user¿s manual prior to using this device.The controller and the wands are designed to be operated as a system.A review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.Factors that could have contributed to the reported event include not having sufficient saline in order to facilitate the formation of plasma, inadequate suction, or not having the wand or foot control connector fully inserted into the controller display.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.There were no indications that would suggest that 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: 10477237
• Report Number: 3006524618-2020-00701
• Device Sequence Number: 16924031
• Product Code: GEI
• UDI-Device Identifier: 00817470006261
• UDI-Public: 00817470006261
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ASC4730-01
• Device Catalogue Number: ASC4730-01
• Device Lot Number: 2040796
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention