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

Catalog Number	138114A
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 three of 138114a in original packaging.Lot number was verified.Performed a visual inspection of the device, there were obvious signs of a breach on two of the devices.Performed a functional inspection on the third device, it was dye leak tested which indicated that the last package had an insufficient heat seal as there was a leak.Root cause cannot be determined, however, based upon evaluation of the device and the ifu; a possible cause of this event could be the package was improperly sealed.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 was conducted and found a total of 3 devices for this lot number.A two-year review of complaint history revealed there has been a total of 221 reports, regarding 1,407 devices, for this device family and failure mode.During this same time frame 10,288,658 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 0.0001.Per the instructions for use, the user is advised the following: sterility guaranteed unless package has been opened, broken, or damaged.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
During incoming inspection, the distributor rejected this device, 138114a, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: h11; a two-year review of complaint history revealed there has been a total of 326 reports, regarding 2,010 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).Received three of 138114a in original packaging.Lot number was verified.Performed a visual inspection of the device, there were obvious signs of a breach on two of the devices.Performed a functional inspection on the third device, it was dye leak tested which indicated that the last package had an insufficient heat seal as there was a leak.Root cause cannot be determined, however, based upon evaluation of the device and the ifu; a possible cause of this event could be the package was improperly sealed.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 was conducted and found a total of 3 devices for this lot number.Per the instructions for use, the user is advised the following: sterility guaranteed unless package has been opened, broken, or damaged.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
During incoming inspection, the distributor rejected this device, 138114a, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: CONMED GOLDLINE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 24518924
• Report Number: 3007305485-2026-00021
• Device Sequence Number: 8522801
• Product Code: GEI
• UDI-Device Identifier: 30653405056298
• UDI-Public: (01)30653405056298(17)290521(10)202405224
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K791137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 138114A
• Device Lot Number: 202405224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic