MAUDE Adverse Event Report: CONMED ULTRACLEAN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	139112EXT
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received four of 139112ext in original packaging.Lot number was verified.Performed a visual inspection of the device, there were obvious signs of a breach on two devices.Performed a functional inspection, the other two devices were dye leak tested which indicated that both packages had an insufficient heat seal as there was a leak.Root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be that the device was encroaching the seal.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 lot history review shows a total of 4 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 224 complaints, regarding 1,397 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 to inspect and test each device before each use.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The distributor reported that the 139112ext device had an insufficient heatseal found during incoming inspection.No patient involvement occurred.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: ULTRACLEAN
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED; 525 french road; utica 13502
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 23830552
• Report Number: 3007305485-2025-00206
• Device Sequence Number: 8954954
• Product Code: GEI
• UDI-Device Identifier: 40653405034774
• UDI-Public: (01)40653405034774(17)280915(10)202309174
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K991855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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: Other
• Device Catalogue Number: 139112EXT
• Device Lot Number: 202309174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic