MAUDE Adverse Event Report: ARTHROCARE CORPORATION COBLATOR II CONTROLLER (240V); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	13546-02
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an ent procedure, a coblator ii controller coagulation mode was not working.Surgery resumed after a delay greater than 30 minutes with a change in the surgical technique.No further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual inspection was performed on the complaint unit and found that the aesthetics are good no damage.A functional inspection was performed on the complaint unit.After open the system it observed that board connectors are disconnected from motherboard , it connected and system working properly.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.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 was associated with unintended use of the device.Factors which could have contributed to the identified malfunction, included an impact event inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: COBLATOR II CONTROLLER (240V)
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18970976
• Report Number: 3006524618-2024-00121
• Device Sequence Number: 12464347
• Product Code: GEI
• UDI-Device Identifier: 00817470002164
• UDI-Public: 00817470002164
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K030108
• 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): 07/16/2024

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: 13546-02
• 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: 03/02/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown