MAUDE Adverse Event Report: UNIVERSAL PLUS-HAND CTL PISTOL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	60-6010-002
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received four 60-6010-002 returned opened in unoriginal packaging.The lot number was verified.A visual inspection did not find any obvious defects or abnormalities.A functional inspection was performed using electro surgical unit system 7550 coag function.Coag button was pressed firmly and coag function activated and deactivated as the button was released.Coag function test was repeated several times and did not show any indication of coag activating without the coag button pressed down.A two-year lot history review was conducted and found no other similar events reported for this lot number.A device history review found no abnormalities that would contribute to this reported event.(b)(4).Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.00004.Per the instructions for use, the user is advised the following: these electrosurgical suction/irrigation instruments should only be used by surgeons trained in surgical endoscopy according to established hospital protocol.Improper use of this or any other electrosurgical device, can result in a patient injury.Read and become familiar with all instructions and directions before using this device.If you do not achieve proper electrosurgical effect with your normal power settings: check the ground pad for proper contact and position.Replace if necessary.Check all electrosurgical cable connections to the esu and the instrument handle.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 the customer that the device, 60-6010-002, was being used on (b)(6) 2021 during an unknown procedure and confirmed that the power output was still going without pushing the coag button.This issue has occurred in 2 cases.(b)(4) was created to capture the second event.The procedure was completed with an unknown alternate device.There was no impact/injury to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: UNIVERSAL PLUS-HAND CTL PISTOL
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• MDR Report Key: 12395871
• Report Number: 3007305485-2021-00357
• Device Sequence Number: 4056055
• Product Code: GEI
• UDI-Device Identifier: 00653405011708
• UDI-Public: (01)00653405011708(17)250615(30)1(10)202006164
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2021

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 Catalogue Number: 60-6010-002
• Device Lot Number: 202006164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 08/31/2021
• Patient Sequence Number: 1