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

Model Number	ASC4730-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an arthroscopy, it was noticed that the cut was not taking place correctly and the tip of the multivac wand was found broken, the metallic part of the tip was found inside the patient.The small piece of metal was retrieved form the patient by being aspirated.Surgery was resumed after a non-significant surgical delay using a back-up device instead.No further complications were reported.
Additional Manufacturer Narrative
H10: 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 an undated photo of the device was provided for review and confirms the reported breakage.Per case details, the broken tip was retrieved from the patient.An intraoperative photo was also provided for review which demonstrates the multivac wand being used at the hip but does not indicate root cause of the broken tip.Conclusion: the image provided was reviewed and does not contribute to a root cause of the breakage, no clinical factors were found which would have contributed to the reported event.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.No further impact to the patient is anticipated as it was noted the broken piece was retrieved.Should additional information become available this issue can be re-elevated.No further clinical assessment is warranted at this time.Factors that could have contributed to the reported event include: hitting the device tip against a hard surface.Using the device as a lever to enlarge surgical site.Mechanical displacement of tissue through applied force.No containment or corrective actions are recommended at this time.

• 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
• 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: 15355759
• Report Number: 3006524618-2022-00390
• Device Sequence Number: 16576043
• Product Code: GEI
• UDI-Device Identifier: 00817470006261
• UDI-Public: 00817470006261
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

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: 12/14/2024
• Device Model Number: ASC4730-01
• Device Catalogue Number: ASC4730-01
• Device Lot Number: 2085814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 09/05/2022
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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
• Patient Sex: Female