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	Foreign Body In Patient (2687)
Date of Event	08/09/2024
Type of Reportable Event	Serious Injury
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 being used during a laparoscopic exploration for infection / lysis of adhesions procedure on (b)(6) 2024, and ¿defective kittners fell off in mid-surgery¿.There was a search for the missing kittners.The procedure was completed without the use of an alternate device and with a delay of 20 minutes.Further assessment found that a fragment or component fell into the surgical site, and the surgical team was "unable to find" them; therefore, all fragments or components were not retrieved.There was no medical/surgical intervention or extended hospitalization required for the patient, and the patient's condition is "stable".This report is being raised on the basis of injury due retained foreign body, as all fragments or components could not be found after falling into the patient.
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 for trends through the complaint system to assure patient safety.H3 other text: device not yet received.
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 6 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 8 reports, regarding 11 devices, for this device family and failure mode.During this same time frame 1,765 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 0.006.Per the instructions for use, the user is advised the following: 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.
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 being used during a laparoscopic exploration for infection / lysis of adhesions procedure on 09aug24, and ¿defective kittners fell off in mid-surgery¿.There was a search for the missing kittners.The procedure was completed without the use of an alternate device and with a delay of 20 minutes.Further assessment found that a fragment or component fell into the surgical site, and the surgical team was "unable to find" them; therefore, all fragments or components were not retrieved.There was no medical/surgical intervention or extended hospitalization required for the patient, and the patient's condition is "stable".This report is being raised on the basis of injury due to retained foreign body, as all fragments or components could not be found after falling into the patient.
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 being used during a laparoscopic exploration for infection / lysis of adhesions procedure on 09aug24, and ¿defective kittners fell off in mid-surgery¿.There was a search for the missing kittners.The procedure was completed without the use of an alternate device and with a delay of 20 minutes.Further assessment found that a fragment or component fell into the surgical site, and the surgical team was "unable to find" them; therefore, all fragments or components were not retrieved.There was no medical/surgical intervention or extended hospitalization required for the patient, and the patient's condition is "stable".This report is being raised on the basis of injury due to retained foreign body, as all fragments or components could not be found after falling into the patient.
Additional Manufacturer Narrative
This correction updates information previously provided in follow-up report #1, which was based on data from an incorrect shipping units report: a two-year review of complaint history revealed there has been a total of 9 reports, regarding 12 devices, for this device family and failure mode.During this same time frame 54,645 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 0.0002.(end of correction) 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 6 devices for this lot number and failure mode.Per the instructions for use, the user is advised the following: 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 20290337
• Report Number: 1320894-2024-00256
• Device Sequence Number: 7284161
• Product Code: GCJ
• UDI-Device Identifier: 20653405043277
• UDI-Public: (01)20653405043277(17)290707(10)202407081
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CD801
• Device Lot Number: 202407081
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 10/16/2024; 11/07/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/28/2024; 11/08/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic