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	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This complaint was created by the finding of maude report number (b)(4).The account and contact information for this report are not known.The current complaint database has been researched for this event and there were no findings.The cd801, 5mm laparoscopic kittner, blunt dissector 40 cm length was being used on (b)(6) 2024 and ¿during the lap chole the sponge on the laparoscopic kittner fell off the applicator.The surgeon noticed this right away and retrieved the sponge.The needs to be reported as a factory defect.¿.This was reported as a product problem not an adverse event.There was no impact or injury to the patient ¿no clinical signs, symptoms or conditions¿.Due to the reporter being anonymous conmed is unable to request further information.This report is being raised due to the reported 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.
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.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).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
This complaint was created by the finding of maude report number (b)(4).The account and contact information for this report are not known.The current complaint database has been researched for this event and there were no findings.The cd801, 5mm laparoscopic kittner, blunt dissector 40 cm length was being used on (b)(6) 2024 and ¿during the lap chole the sponge on the laparoscopic kittner fell off the applicator.The surgeon noticed this right away and retrieved the sponge.The needs to be reported as a factory defect.¿.This was reported as a product problem not an adverse event.There was no impact or injury to the patient ¿no clinical signs, symptoms or conditions¿.Due to the reporter being anonymous conmed is unable to request further information.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
This complaint was created by the finding of maude report number (b)(4).The account and contact information for this report are not known.The current complaint database has been researched for this event and there were no findings.The cd801, 5 mm laparoscopic kittner, blunt dissector 40 cm length was being used on (b)(6) 2024 and "during the lap chole the sponge on the laparoscopic kittner fell off the applicator.The surgeon noticed this right away and retrieved the sponge.The needs to be reported as a factory defect".This was reported as a product problem not an adverse event.There was no impact or injury to the patient "no clinical signs, symptoms or conditions".Due to the reporter being anonymous conmed is unable to request further information.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
At request from fda; update to block h10 with maude number.
Event or Problem Description
This complaint was created by the finding of maude report number (b)(4).The account and contact information for this report are not known.The current complaint database has been researched for this event and there were no findings.The cd801, 5 mm laparoscopic kittner, blunt dissector 40 cm length was being used on (b)(6) 2024 and "during the lap chole the sponge on the laparoscopic kittner fell off the applicator.The surgeon noticed this right away and retrieved the sponge.The needs to be reported as a factory defect".This was reported as a product problem not an adverse event.There was no impact or injury to the patient "no clinical signs, symptoms or conditions".Due to the reporter being anonymous conmed is unable to request further information.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
At request from fda; update to block h10 with medsun number.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 20248773
• Report Number: 1320894-2024-00251
• Device Sequence Number: 17962404
• Product Code: GCJ
• UDI-Device Identifier: 20653405043277
• UDI-Public: (01)20653405043277(17)280923(10)202309251
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K955490
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/30/2025

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: 202309251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 10/03/2024; 12/23/2024; 01/30/2025
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/28/2024; 01/06/2025; 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2023
• 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 Age: 62 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic