MAUDE Adverse Event Report: CONMED UTICA DTIP GRSP,STRT FENSTD,43CM,5MM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	2-4307
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	05/09/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer reported that the device, 2-4307 dtip grsp,strt fenstd,43cm,5mm was being used during a bariatric roux-en-y procedure on (b)(6) 2024 and ¿the tip broke off into the patient.¿ per further assessment it was found that it was the distal end of the blue insulation that fragmented, and it was recovered from the patient.There was no report of injury, medical intervention, or hospitalization for the patient or user.The patient status is ¿satisfactory¿.The procedure was completed and there was a small delay to obtain a new instrument.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device has not been returned to date 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.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: inspect the shaft insulation and luer lock port for dents, breaks, or damage before and after each use.If insulation is nicked or damaged, do not use.Failure to observe this warning with every use may result in injury or electric shock to the patient or operating room personnel when the instrument is used with an electrosurgical unit.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, 2-4307 dtip grsp,strt fenstd,43cm,5mm was being used during a bariatric roux-en-y procedure on (b)(6) 2024 and ¿the tip broke off into the patient.¿ per further assessment it was found that it was the distal end of the blue insulation that fragmented, and it was recovered from the patient.There was no report of injury, medical intervention, or hospitalization for the patient or user.The patient status is ¿satisfactory¿.The procedure was completed and there was a small delay to obtain a new instrument.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: DTIP GRSP,STRT FENSTD,43CM,5MM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 19390266
• Report Number: 1320894-2024-00138
• Device Sequence Number: 6786314
• Product Code: GEI
• UDI-Device Identifier: 20653405059452
• UDI-Public: (01)20653405059452(17)290217(10)202402191
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K924283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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: 2-4307
• Device Lot Number: 202402191
• 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: 05/09/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic