MAUDE Adverse Event Report: CONMED CORPORATION ULTRABLATOR 90 DEGREE, THREE RIB, 130MM LENGTH, 3.2MM DIAMETER, QTY 5; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ESA-5379
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual examination of the returned device found that a portion of the epoxy insulation is missing close to the electrode.No loose pieces were returned with the device.The ceramic insulator appears intact and undamaged.The electrode shows evidence of extensive usage and there are numerous wear marks and scratches on the epoxy insulation.There are no fractures in the hub or other abnormal observations of this device.The degree of electrode wear and marks on th epoxy suggests extensive usage of this device, including mechanical stresses from contact with another instrument or cannula.The condition of the exposed electrode indicates continued usage after the epoxy coating was first compromised.The epoxy is applied in a power coated process, and may have been at the lower end of the thickness specification.The combined effects of a thinner coating, coupled with mechanical damage, and continued usage after the initial break in the coating, likely led to the observed failure.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 were 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 (b)(4) complaints, regarding (b)(4) 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: warnings: 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 use care when inserting into and withdrawing the electrode from a cannula to avoid the possibility of damage to the device and/or injury to the patient.Maintain the active electrode tip in the field of view at all times.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
This distributor reported that the esa-5379, ultrablator 90 degree, three rib, 130mm length, 3.2mm diameter, qty 5, device was found to have a hole in the device's shaft cover near the tip during use.This was discovered during a procedure on (b)(6) 2018.The type of procedure being performed is unknown, as well as if this event caused a delay.It was reported; however, that the device components did not require retrieval as no component of the device fell into the surgical site.The reporter stated that there was no injury to the patient or user.And there was no extended stay of hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: ULTRABLATOR 90 DEGREE, THREE RIB, 130MM LENGTH, 3.2MM DIAMETER, QTY 5
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 7610813
• Report Number: 1017294-2018-00078
• Device Sequence Number: 121972
• Product Code: GEI
• UDI-Device Identifier: 10845854029589
• UDI-Public: (01)10845854029589(17)230131(30)1(10)902745
• 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: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2018

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: Physician
• Device Expiration Date: 01/31/2023
• Device Model Number: ESA-5379
• Device Catalogue Number: ESA-5379
• Device Lot Number: 902745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1