MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY ULTRCLN 1 IN. NEDL W/EXTND INSULATION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	139105EXT
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
Conmed canada reported on behalf of the customer that the 139105ext, ultrcln 1 in.Nedl w/extnd insulation was being used during a tonsils and adenoids procedure on 14mar23 when it was reported ¿once started using the cautery, tip lit on fire, and fire had to be extinguished.Second tip opened and no issue (unsure if it was cautery or the tip)." further assessment questioning found that the device did not make patient contact at the time of this incident and ¿we switched to a new cautery set up and completed the case¿.It was confirmed that the patient was not diagnosed with a burn.The procedure was completed with a 5-minute delay and there was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.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 5 complaints, regarding 5 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: use lowest possible power setting on the associated electrosurgical unit capable of achieving desired surgical effects.Activation time should be as short as possible.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
Conmed canada reported on behalf of the customer that the 139105ext, ultrcln 1 in.Nedl w/extnd insulation was being used during a tonsils and adenoids procedure on (b)(6) 2023 when it was reported ¿once started using the cautery, tip lit on fire, and fire had to be extinguished.Second tip opened and no issue (unsure if it was cautery or the tip)." further assessment questioning found that the device did not make patient contact at the time of this incident and ¿we switched to a new cautery set up and completed the case¿.It was confirmed that the patient was not diagnosed with a burn.The procedure was completed with a 5-minute delay and there was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: ULTRCLN 1 IN. NEDL W/EXTND INSULATION
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 16708496
• Report Number: 3007305485-2023-00078
• Device Sequence Number: 3628515
• Product Code: GEI
• UDI-Device Identifier: 40653405033258
• UDI-Public: (01)40653405033258(17)270216(10)202202175
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K991855
• 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): 04/21/2023

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: 139105EXT
• Device Catalogue Number: 139105EXT
• Device Lot Number: 202202175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic