MAUDE Adverse Event Report: CONMED UTICA UNIVERSAL PLUS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	60-5274-132
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
Conmed japan reported on behalf of their customer that the device, 60-5274-132, laparoscopic electrode with eschar-resistant coating was being used on (b)(6) 2024 during a laparoscopic cholecystectomy and ¿during use, the electrode tip came off.The part that fell into the body was retrieved.In the first device, the electrode came off while being wiped outside the body.Therefore, the facility replaced it to the same new device.However, the replaced electrode came off inside the patient's body while it was being replaced and used.The detached electrode was retrieved with forceps.¿.The procedure was completed with an alternate same device.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
Conmed japan reported on behalf of their customer that the device, 60-5274-132, laparoscopic electrode with eschar-resistant coating was being used on (b)(6) 2024 during a laparoscopic cholecystectomy and ¿during use, the electrode tip came off.The part that fell into the body was retrieved.In the first device, the electrode came off while being wiped outside the body.Therefore, the facility replaced it to the same new device.However, the replaced electrode came off inside the patient's body while it was being replaced and used.The detached electrode was retrieved with forceps.¿ the procedure was completed with an alternate same device.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received two 60-5274-132 in opened original packaging.Lot number was verified.Performed a visual inspection, the tips are missing from the devices and were returned separately.There is evidence on the electrodes of soldering.A root cause cannot be determined, however, based upon the evaluation of the device and the photos, a likely cause may be due to excessive force being used during removal of eschar from the tip.A two-year lot history review shows a total of 3 devices for this lot number and failure mode.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.A two-year review of complaint history revealed there has been a total of 28 reports, regarding 29 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: to avoid potential damage to trocar seals and to the electrosurgical tip, always slide the tip shield in the covered and locked position during insertion into the trocar cannula.Misuse 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.During trocar insertion, always have the electrode tip covered to avoid potential damage to trocar seals and the electrode tip.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: UNIVERSAL PLUS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 20523536
• Report Number: 1320894-2024-00367
• Device Sequence Number: 18434598
• Product Code: GEI
• UDI-Device Identifier: 30653405010733
• UDI-Public: (01)30653405010733(17)280708(10)202307101
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K952204
• 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): 11/25/2024

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: 60-5274-132
• Device Lot Number: 202307101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic