MAUDE Adverse Event Report: CONMED LARGO ULTRABLATOR 90 DEGREE, 110MM LENGTH, 3.2MM DIAMETER, QTY 5; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ESA-5396
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event is inconclusive.The device will not be returned for evaluation and no photographic evidence has been provided; therefore, the reported event 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 two reports, regarding two 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 0.00006.Per the instructions for use, the user is advised the following: when electrosurgical pencil is not in use, place it in a safety holster.Electrodes must only be used in a conductive fluid medium to avoid insulation damage.If any visual defects are noticed in the insulation, or the ceramic/insulation is damaged in any way, stop using the device immediately and replace the device.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
Conmed (b)(4) reported on behalf of their customer that the device, esa-5396, ultrablator 90 degree, 110mm length, 3.2mm diameter was being used on (b)(6) 2022 during an unknown procedure when it was reported ¿it was confirmed that the device had a hole in the tip, so the customer used another device.The surgery was succeeded without any problems.¿ an alternate device of the same was used.Further assessment found that ¿a fragment was not confirmed¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: ULTRABLATOR 90 DEGREE, 110MM LENGTH, 3.2MM DIAMETER, QTY 5
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 14193482
• Report Number: 1017294-2022-00048
• Device Sequence Number: 17255090
• Product Code: GEI
• UDI-Device Identifier: 10845854020623
• UDI-Public: (01)10845854020623(17)260831(30)1(10)1191383
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2022

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 Expiration Date: 08/31/2026
• Device Model Number: ESA-5396
• Device Catalogue Number: ESA-5396
• Device Lot Number: 1191383
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic