MAUDE Adverse Event Report: ARTHROCARE CORPORATION SUPER TURBOVAC 90 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	ASC4250-01
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder arthroscopy, the electrode of the handle and shaft of the super turbovac 90 icw became unusually warm, the electrode tip in the joint had a much brighter light visible, instead of the usual glowing light (nacl).The irrigation fluid was also noticeably warmer than usual.The procedure was resumed, without any delay, using an equivalent s+n back-up.No harm or further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10, h3, h6: the reported device was not returned for evaluation; however, a different device was received and evaluated.Visual inspection observed the returned instrument shows no manufacturing abnormalities.The device was returned with all of its packaging, and the outer box was opened but the inner packaging is fully sealed.The wand is not used.The wand was opened and had no visual issues.The device was plugged into the controller and registered settings (1,7).The wand had no issues producing plasma or activating coag.The resistance measured at 0.90 kilo ohms.The output of the wand was normal and no abnormal heating occurred in testing.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 root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include 1) used non-conductive media.2) contact with metal objects while activating the wand.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: SUPER TURBOVAC 90 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: 23460396
• Report Number: 3006524618-2025-00634
• Device Sequence Number: 18743997
• Product Code: GEI
• UDI-Device Identifier: 00817470006421
• UDI-Public: 00817470006421
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/09/2025

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 Catalogue Number: ASC4250-01
• Device Lot Number: 2182800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2025
• 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
• Patient Sex: Unknown