MAUDE Adverse Event Report: CONMED UTICA ELEC,BLDE,STD,EXT,INSULATED,40; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	138104
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 five 138104 in unopened original packaging.Lot number was verified.Performed a visual inspection of the device, there were no obvious signs of a breach in the seal however, the device was encroaching into the seal.Performed a functional inspection, the devices were dye leak tested which indicated that the packaging had an insufficient heat seal on one of the five packages.Root cause cannot be determined, however, based upon a completed review of the manufacturing process, it indicated that a possible cause of this event could be due to a worn-out belt.A two-year lot history review was conducted and found a total of 5 devices for this lot number.A device history record review found a quality excursion report related to the reported event.This report was reviewed during manufacturing and determined that further action is not needed.A two-year review of complaint history revealed there has been a total of 270 reports, regarding 8,091 devices, for this device family and failure mode.During this same time frame 8,913,998 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: inspect and test each device before each use.Sterility guaranteed unless package has been opened, broken, or damaged.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
During incoming inspection, the distributor rejected this device, 138104, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.Performed a visual inspection of the device, there were no obvious signs of a breach in the seal however, the device was encroaching into the seal.Performed a functional inspection, the devices were dye leak tested which indicated that the packaging had an insufficient heat seal this will be reported as a malfunction with potential for injury upon reoccurrence.

• Brand Name: ELEC,BLDE,STD,EXT,INSULATED,40
• 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: 17919600
• Report Number: 1320894-2023-00211
• Device Sequence Number: 17810392
• Product Code: GEI
• UDI-Device Identifier: 30653405003391
• UDI-Public: (01)30653405003391(17)261121(10)202111221
• 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): 10/12/2023

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: 138104
• Device Lot Number: 202111221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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