MAUDE Adverse Event Report: CONMED 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the cd801, 5mm laparoscopic kittner, blunt dissector 40 cm length device was used in an unknown procedure on an unknown date and, ¿in some cases, the white pad is not attached to the instrument when the envelope is closed, and in other cases during the procedure, and comes off very easily.¿.Further assessment found ¿it almost always happened before inserting the instrument into the trocar.¿.There was no report of injury, medical/surgical intervention or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
A sales representative reported on behalf of a customer that the cd801, 5mm laparoscopic kittner, blunt dissector 40 cm length device was used in an unknown procedure on an unknown date and, ¿in some cases, the white pad is not attached to the instrument when the envelope is closed, and in other cases during the procedure, and comes off very easily.¿ further assessment found ¿it almost always happened before inserting the instrument into the trocar.¿ there was no report of injury, medical/surgical intervention or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event of ¿the white pad is not attached to the instrument¿ was confirmed.The device will not be returned for evaluation, but photographic evidence has been provided.Root cause cannot be determined, however, based upon photographic evidence; a possible cause of this event could be excessive force.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 seven (7) devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 29 reports, regarding 39 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.

• Brand Name: CORE DYNAMICS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED; 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: 23990204
• Report Number: 1320894-2026-00005
• Device Sequence Number: 10536243
• Product Code: GCJ
• UDI-Device Identifier: 20653405043277
• UDI-Public: (01)20653405043277(17)300323(10)202503241
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: Health Professional
• Device Catalogue Number: CD801
• Device Lot Number: 202503241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic