MAUDE Adverse Event Report: ARTHROCARE CORPORATION PROCISE MAX COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	EIC8898-01
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ent procedure, a procise max coblator ii was smoking, despite being checked the suction tube became hot; and when it was retrieved the tonsillar tissue "burned" without spraying it; however no consequences took place.Surgery resumed after a non-significant delay less than 30 minutes, with a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that during an ent procedure, a procise max coblator ii was smoking, despite being checked the suction tube became hot; and when it was retrieved the tonsillar tissue "burned" without spraying it; which caused that the tonsillar tissue to become more dense; however no consequences took place.The device was initially being used in a 9 setting, which was reduced to 7 and lastly to 5.Surgery resumed after a non-significant delay less than 30 minutes, with a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H10: h2: additional information: b5: event description and h6: health effect - impact code.
Additional Manufacturer Narrative
H10: internal complaint reference case-(b)(4).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.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, 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.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: PROCISE MAX COBLATOR II
• 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: 18378123
• Report Number: 3006524618-2023-00514
• Device Sequence Number: 20760982
• Product Code: GEI
• UDI-Device Identifier: 00817470007473
• UDI-Public: 00817470007473
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K202006
• 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,Followup
• Report Date (Section B): 03/05/2024

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: EIC8898-01
• Device Lot Number: UNKNOWN
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 12/21/2023; 03/04/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/09/2024; 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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