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

Model Number	ASC4630-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a knee joint cleaning, the tristar wand tip fell off.The broken piece was removed from the patient using tweezers.The procedure was successfully completed with a delay greater than 30 minutes, using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H10: h2: additional information on b2.H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states this case reports, during a knee joint cleaning, the tristar wand tip fell off.According to the report, the broken piece was removed from the patient using tweezers.According to the product evaluation, a visual inspection of the single undated, unlabeled customer provided image shows an arthroscopic view of the detached electrode.No other clinical information was provided.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Conclusion: based on a review of the information provided, the definitive clinical root cause of the reported failure could not be determined.According to the report, all the broken pieces were removed from inside of the patient with tweezers and the surgery was completed with a greater than 30 minutes delay using a back-up device.Since there was no alleged harm to this patient due to the greater than thirty minutes surgical delay and no other complications have been reported, no further clinical/medical assessment is warranted at this time.There was a relationship found between the device and the reported event.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include: (1) hitting the device tip against a hard surface.(2) using the device as a lever to enlarge surgical site.(3) mechanical displacement of tissue through applied force.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: SUPER MULTIVAC 50 ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15835050
• Report Number: 3006524618-2022-00484
• Device Sequence Number: 5426903
• Product Code: GEI
• UDI-Device Identifier: 00817470001921
• UDI-Public: 00817470001921
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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 Expiration Date: 05/18/2024
• Device Model Number: ASC4630-01
• Device Catalogue Number: ASC4830-01
• Device Lot Number: 2073656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 12/08/2022
• Date Device Manufactured: 05/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Female