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

Catalog Number	13546-02
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Event or Problem Description
It was reported that during an unknown procedure, the coblator generator was not registering that the flow control unit was attached to the unit, however, when pressing on the foot control assembly, with a wand attached to the generator, the pin within the flow control unit would start to flicker on and off.The pin within the flow control unit was never permanently open to feed the saline line through.The user tested the generator with different flow control units and cables but still had the same issue.The procedure was cancelled.No further complication reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).

• 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: 19589132
• Report Number: 3006524618-2024-00235
• Device Sequence Number: 14281553
• Product Code: GEI
• UDI-Device Identifier: 00817470001976
• UDI-Public: 00817470001976
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/18/2024
• 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