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

Catalog Number ESA-5379

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

The exact date of event is unknown, only that is was on or before (b)(6) 2021.At time of filing, the reported device is not expected to be returned to conmed for evaluation.This reported event is entering the investigation process.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the customer, (b)(6).Received notification of reported issues with the ultrablator 90 degree, three rib, 130mm length, 3.2mm diameter, item # (b)(4), unknown serial number, that occurred at thunder bay regional health sciences centre, ontario.The exact date of event is unknown, only that is was on or before (b)(6) 2021.It was reported that the tbrhsc surgeon is experiencing ongoing electrical shocks while using the conmed ablator cautery.The doctor gets shocked every time she does a left shoulder arthroscopy.She leans on the patient while operating and gets a shock on her gown sleeve, just above her latex glove.After further discussion it was provided that the doctor is short and when she leans against the patient doing a shoulder with the ablator, she gets a shock between her glove and gown.Additional information received indicates the console involved is a valleylab medtonic device.The settings and cord used and what the console was plugged into are all unknown.It was indicated the biomed department of facility was spoken to & they note that the shocking is all user error.They state it is more like a tingling she is getting.The doctor was observed, and it is noted that she leans all over the patient when she's using the ablator.The valley lab representative has been to the facility several times to check out everything as well as the biomed department and there is nothing wrong with the unit.It was confirmed that surgeon reports being shocked, however there is no injury, no burn/blister, etc.This tingling lasts as long as the doctor is leaning on the patient, not immediately when unit plugged in & occurs only when she leans on patient.It is indicated the procedure was completed and there was no impact to the patient or lasting impact to the user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Investigation of the customer's reported issue and complaint was inconclusive.The device in question, used in the procedure, is not available for evaluation by conmed.No photographic evidence has been provided.Therefore, the reported failure cannot be verified, nor a root cause determined.As a lot number was not provided, conmed could not conduct a two-year lot history review or review the manufacturing documents from the device history record.A two-year review of complaint history revealed there has been a total of 1 complaint, regarding (b)(4) device, 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).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu also advises the user that this equipment is capable of producing a physiological effect and is for use only by licensed physicians trained in the use of this device.Examine all accessories and connections to the generator before use.Ensure all accessories are properly and securely connected and function as intended.Improper connection may result in arcing, sparking, or malfunction of the device, any of which can result in an unintended surgical effect, injury, or equipment damage.Do not wrap ablator, footswitch, or generator power cord around metal objects.Wrapping cables around metal objects may induce currents that could lead to shock, fire or injury to patient or surgical personnel.The concept ablator electrodes are recommended for use with conmed electrosurgical pencils and conmed electrosurgical generators.Other electrosurgical generators may be used given the following: the electrosurgical generator allows connection of the conmed electrosurgical pencil's three prong connector.The electrosurgical generator can be set to the associated power setting for the cut and coag modes without exceeding the associated maximum rated voltage for each mode, reference 'setting and rated voltage" section.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: ULTRABLATOR 90 DEGREE, THREE RIB, 130MM LENGTH, 3.2MM DIAMETER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• MDR Report Key: 11455114
• MDR Text Key: 242863012
• Report Number: 1017294-2021-00121
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K030720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ESA-5379
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDTRONIC VALLEYLAB CONSOLE