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

Catalog Number	138100
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
Event or Problem Description
The distributor reported that the 138100 device had an insufficient heatseal found during incoming inspection.No patient involvement occurred.The shipment associated with the rga for this device has not yet been returned for evaluation and it has not been confirmed that an insufficient heatseal causing a sterility breach has occurred.Based on the information available, and the decision tree results, this complaint does not meet the definition of a reportable event.Upon the receipt of the device, an evaluation will be conducted and if a breach of sterility is confirmed the reporting decision will be reassessed at that time.Update: the device was returned and evaluated.The completion of the device evaluation confirmed an insufficient heatseal; therefore, this complaint has been reassessed and meets the criteria for a reportable event.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received 1 of item 138100 in unopened original packaging.Performed a visual inspection of the device, there were no obvious signs of a breach.Performed a functional inspection, the device was dye leak tested which indicated that the packaging had insufficient heat seal on the package as there was leakage.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 one (1) device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of (b)(4) reports, regarding (b)(4) devices, for this device family and failure mode.During this same time frame, he device was dye leak tested which indicated that the packaging had insufficient heat seal on the package as there was leakage.Root cause cannot be determined, however, based upon evaluation (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.

• Brand Name: CONMED
• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 21468690
• Report Number: 1320894-2025-00058
• Device Sequence Number: 19727871
• Product Code: GEI
• UDI-Device Identifier: 30653405003322
• UDI-Public: (01)30653405003322(17)270731(10)202208011
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943542
• 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): 02/26/2025

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: 138100
• Device Lot Number: 202208011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic