MAUDE Adverse Event Report: CONMED UTICA CORE DYNAMICS; CANNULA AND TROCAR, SUPRAPUBIC, NON-DISPOSABLE

Catalog Number	CD612
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
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 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 cd612, enii 5/10/12mm val flptop rdcr was being used on 13jun24 during an endocholecystectomy procedure when it was reported ¿the disposable part of our core trocars fell into the abdominal cavity during the procedure.It was seen right away and retrieved.¿.The procedure was completed without the use of an alternate device.The was a 5-minute delay reported and ¿since it was seen and retrieved right away, there was no impact on the patient.¿.There was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
D1 brand name was updated from enii 5/10/12mm val flptop rdcr to core dynamics manufacturer narrative: the device will not be returned, and no photographic evidence was provided.Therefore, the reported event 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 1 device for this lot number and failure mode.(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.To prevent damage, the trocar should not be introduced into the cannula valve at an angle.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 cd612, enii 5/10/12mm val flptop rdcr was being used on 13jun24 during an endocholecystectomy procedure when it was reported ¿the disposable part of our core trocars fell into the abdominal cavity during the procedure.It was seen right away and retrieved.¿.The procedure was completed without the use of an alternate device.There was a 5-minute delay reported and ¿since it was seen and retrieved right away, there was no impact on the patient.¿ there was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: CORE DYNAMICS
• Common Device Name: CANNULA AND TROCAR, SUPRAPUBIC, NON-DISPOSABLE
• 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: 19655339
• Report Number: 1320894-2024-00169
• Device Sequence Number: 6904966
• Product Code: FBM
• UDI-Device Identifier: 10653405045861
• UDI-Public: (01)10653405045861(17)280408(10)202304101
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K911813
• 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): 08/13/2024

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: CD612
• Device Lot Number: 202304101
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic