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

Catalog Number EIC8898-01

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

H10: internal complaint reference: case-(b)(4).

Event 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.

Manufacturer Narrative

H10: h2: additional information: b5: event description and h6: health effect - impact code.

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
• Type of Device: 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
• MDR Text Key: 331370680
• Report Number: 3006524618-2023-00514
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470007473
• UDI-Public: 00817470007473
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K202006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: EIC8898-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 12/21/2023; 03/04/2024
• Supplement Dates FDA Received: 01/09/2024; 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1