MAUDE Adverse Event Report: CONMED UTICA CORE DYNAMICS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	CD801
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	12/27/2024
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 per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the device, cd801, 5mm laparoscopic kittner, blunt dissector 40 cm length, was being opened for an unknown procedure on (b)(6) 2024 when it was reported, ¿ when opening the device, the white pad detaches.¿.There was no report of patient involvement; therefore, there was no injury, medical intervention, or hospitalization to be reported.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Examination of the returned unused unopened device cd801 found that the white pad did detach.Received (b)(4) of the cd801 5mm laparoscopic kittner, blunt dissector in unopened original packaging.Sampled (b)(4) devices per wi-qa-10-47 and aql of 1.0 and visually inspected to find that (b)(4) devices out of (b)(4) had the white pads detach.Root cause cannot be determined, however, based upon evaluation of the device, the results of the manufacturing review process, and photos; a possible cause of this event could be transportation conditions.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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding (b)(4) 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).We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the device, cd801, 5mm laparoscopic kittner, blunt dissector 40 cm length, was being opened for an unknown procedure on (b)(6) 2024 when it was reported, ¿when opening the device, the white pad detaches.¿.There was no report of patient involvement; therefore, there was no injury, medical intervention, or hospitalization to be reported.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: CORE DYNAMICS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 21251235
• Report Number: 1320894-2025-00027
• Device Sequence Number: 9116852
• Product Code: GCJ
• UDI-Device Identifier: 20653405043277
• UDI-Public: (01)20653405043277(17)290804(10)202408051
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K955490
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: Health Professional
• Device Catalogue Number: CD801
• Device Lot Number: 202408051
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic