MAUDE Adverse Event Report: CONMED LARGO 130MM X 2.3MM DIAMETER, CONCEPT HEATWAVE ELECTRODE, QTY 5; ELECTRODE, ELECTROSURGICAL

Model Number	CS-023
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device is not being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported on behalf of the device, cs-023, 130mm x 2.3mm diameter, concept heatwave electrode, qty 5 was used during an unknown procedure on the approximate date of (b)(6) 2023, when it was reported, ¿during the surgery item is broken¿.After further assessment, it was reported the device did fragment, but it was retrieved with the shaver suction.There was no patient or user injury, prolonged hospitalization, or medical intervention.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Visual examination of returned used, item cs-023 found the coating (insulation) burned at the shaft tip.Also, electrode shaft was bent in the middle of the shaft.High power generator settings, and prolonged use, may result in damage to the insulation, melting of the electrode tip or increased risk of patient burns.Excessive twisting forces may have attributed to the failure of the insulator inside a cannula or incidental hitting of another hard object.Examination performed per print cs-023.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 2 complaints, regarding 3 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: do not pry or pull tissue using the device.Insulation may be damaged.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported on behalf of the device, cs-023, 130mm x 2.3mm diameter, concept heatwave electrode, qty 5 was used during an unknown procedure on the approximate date of (b)(6) 2023, when it was reported, ¿during the surgery item is broken¿.After further assessment, it was reported the device did fragment, but it was retrieved with the shaver suction.There was no patient or user injury, prolonged hospitalization, or medical intervention.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 130MM X 2.3MM DIAMETER, CONCEPT HEATWAVE ELECTRODE, QTY 5
• Common Device Name: ELECTRODE, ELECTROSURGICAL
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 16631279
• Report Number: 1017294-2023-00025
• Device Sequence Number: 20161324
• Product Code: JOS
• UDI-Device Identifier: 10845854021859
• UDI-Public: (01)10845854021859(17)270725(30)1(10)1261196
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K991830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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 Model Number: CS-023
• Device Catalogue Number: CS-023
• Device Lot Number: 1261196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic