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	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer, that the cd801, 5mm laparoscopic kittner, blunt dissector 40 cm length was being used on (b)(6) 2024 during a laparoscopic cholecystectomy procedure when it was reported ¿during a laparoscopic cholecystectomy the tip of the kittner fell off and was retrieved inside the abdominal cavity.It was successfully removed.¿.The procedure was completed and there was no report if injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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 for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer, that the cd801, 5mm laparoscopic kittner, blunt dissector 40 cm length was being used on (b)(6)2024 during a laparoscopic cholecystectomy procedure when it was reported ¿during a laparoscopic cholecystectomy the tip of the kittner fell off and was retrieved inside the abdominal cavity.It was successfully removed.¿.The procedure was completed and there was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.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 (b)(4) devices for this lot number and failure mode; however, one was confirmed.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).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 for trends through the complaint system to assure patient safety.

• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 20450728
• Report Number: 1320894-2024-00273
• Device Sequence Number: 12892796
• Product Code: GCJ
• UDI-Device Identifier: 20653405043277
• UDI-Public: (01)20653405043277(17)290707(10)202407081
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K955490
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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: 202407081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic