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

Catalog Number	CD801
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported on behalf of their customer that the device, (b)(6), 5mm laparoscopic kittner, blunt dissector 40 cm length, was being used during a laparoscopic cholecystectomy procedure on an unknown date when it was reported, ¿this past weekend we had two 5mm lap kittners (ref# (b)(4)) fall apart during the surgery.We saved the item and the packaging.¿.There was no report of injury, medical intervention, or hospitalization for the patient.There was no report of fragmentation contact with the patient.The procedure was completed without any delay being reported.The patient was discharged as planned.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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.
Additional Manufacturer Narrative
Examination of returned used device cd801 found that the device was intact.Examination was done per print.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 8 complaints, regarding 12 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 that a thorough understanding of the principles and techniques involved in laparoscopic laser and electrosurgical procedures is essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device or other medical instruments.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the device, cd801, 5mm laparoscopic kittner, blunt dissector 40 cm length, was being used during a laparoscopic cholecystectomy procedure on an unknown date when it was reported, ¿this past weekend we had two 5mm lap kittners (ref# (b)(4) fall apart during the surgery.We saved the item and the packaging.¿.There was no report of injury, medical intervention, or hospitalization for the patient.There was no report of fragmentation contact with the patient.The procedure was completed without any delay being reported.The patient was discharged as planned.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: 21490199
• Report Number: 1320894-2025-00060
• Device Sequence Number: 12870651
• Product Code: GCJ
• UDI-Device Identifier: 20653405043277
• UDI-Public: (01)20653405043277(17)291110(10)202411111
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K955490
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• 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: 202411111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic