MAUDE Adverse Event Report: Arthrocare Corporation SUPER TURBOVAC 90 ICW; Electrosurgical, Cutting & Coagulation & Accessories

Catalog Number	ASC4250-01
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction

• 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 ; +1(512)391-3905
• MDR Report Key: 50576892
• Report Number: 3006524618-2026-00457
• Device Sequence Number: 9872288
• Product Code: GEI
• UDI-Device Identifier: 00817470006421
• UDI-Public: 00817470006421
• 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,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: 2176222
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 09/03/2026
• 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