MAUDE Adverse Event Report: ARTHROCARE CORPORATION FA COBLATOR II CONTROLLER (120V); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	13546-01
Medical Device Problem Codes	Failure to Deliver Energy (1211); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a t&a, four evac 70 wands failed when connected to the controller.Two wands would register settings for ablate and coag but would not deliver energy, and the other two wands would register settings 0's for ablate and coag options when plugged in.The fa coblator controller, the settings registered on the controller, but it was not delivering the energy to the tissue.The procedure was cancelled.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).D10, concomitants part numbers and lot numbers: the following are the part numbers and lot numbers reported: pn: eica5872-01 and lot numbers: 2147289 (2 devices) and 2131995 (2 devices).All of the devices mentioned contributed to the cancellation of the procedure.D4, exp.Date: expiration dates for each of the 2 lots reported: 21-feb-2027 (2147289), 27-sep-2026 (2131995).H4, mgf.Date: manufacturing dates for each of the 2 lots reported: 21-feb-2024 (2147289), 27-sep-2023 (2131995).
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H10 h3, h6: the reported device was received for evaluation.A visual inspection observed the power button is jammed in the on position and the lid and bezel are damaged.A functional evaluation revealed the unit can be turned on by plugging in power.The unit had no issues producing output voltage to wands.No accessories were returned with this device.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 rough handling or excessive force to the device.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: FA COBLATOR II CONTROLLER (120V)
• 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: 19746878
• Report Number: 3006524618-2024-00266
• Device Sequence Number: 17775182
• Product Code: GEI
• UDI-Device Identifier: 00817470001976
• UDI-Public: 00817470001976
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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: 13546-01
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EICA5872-01
• Patient Sex: Unknown