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

Catalog Number	ASC4830-01
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroplasty, the tip electrode of the super multivac 50 wand detached and fell inside the patient; the electrode was not retrieved from within the patient.The procedure was resumed using an equivalent s+n backup.It is unknown whether any delay occurred.No further complications were reported.
Additional Manufacturer Narrative
H11: h3, h6: the reported device was received for evaluation.A visual inspection observed the returned instrument shows no manufacturing abnormalities.Product was out of the original packaging.No packaging returned.The tip is worn from use.The electrode is missing from the tip and only the stands inside the spacer remain.A functional evaluation was performed on the returned device and found the wand cannot be tested further due to the damaged electrode.The resistance measured at 0.91 kilo ohms.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.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.The instructions for use were 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 clinical review states that this device was manufactured and intended as an externally communicating device and it has not been approved for long-term tissue exposure and long-term implantation data is unavailable.However, we are unable to make any conclusion on the impact of the non-implantable foreign body.Since it is unclear whether the electrode tip was left secure, we cannot rule out the potential for micro-motion, migration and local irritation/discomfort.The patient's impact beyond the retained electrode tip cannot be determined with the limited information provided.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences ((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.4) activating the device above recommended settings for prolonged periods of time).Based on this investigation, the need for corrective action is not indicated.

• Brand Name: SUPER MULTIVAC 50 ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23917398
• Report Number: 3006524618-2025-00717
• Device Sequence Number: 18632995
• Product Code: GEI
• UDI-Device Identifier: 00817470003550
• UDI-Public: 817470003550
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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: 05/26/2026
• Device Catalogue Number: ASC4830-01
• Device Lot Number: 2120466
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2023
• 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: Other
• Patient Sex: Unknown