MAUDE Adverse Event Report: CONMED UTICA UNIVERSAL PLUS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	60-5274-032
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Conmed japan reported on behalf of a customer that the 60-5274-032, spatula electrod w/stealth er 5mm x 32cm (5/cs) device was being used during an unnamed procedure on (b)(6) 2024, and ¿the tip of electrode was detached during surgery¿.Follow-up assessment ¿confirmed the electrode came off after being removed from the patient's body.However, they were unable to obtain the procedure type.In this case, even though the device did not fall out of the patient's body, there was a possibility that it might be left behind, so a report must be submitted to the authorities in japan." it was further clarified that "no fragments had fall into the patient's body".There was no report of injury, medical/surgical intervention or extended hospitalization required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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
Received one 60-5274-032 in unoriginal package.Lot number was not verified.Performed a visual inspection, which verified that the tip of the spatula was disassembled.Root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be excessive force.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 3 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 23 reports, regarding 23 devices, for this device family and failure mode.During this same time frame 230,415 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 0.0001.Per the instructions for use, the user is advised the following: misuse of this or any other electrosurgical device can result in a patient injury.Read and become familiar with all instructions and directions before using this device.Examine this device prior to use for damage.Do not use if damage is found.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
Conmed japan reported on behalf of a customer that the 60-5274-032, spatula electrod w/stealth er 5mm x 32cm (5/cs) device was being used during an unnamed procedure on 01aug24, and ¿the tip of electrode was detached during surgery¿.Follow-up assessment ¿confirmed the electrode came off after being removed from the patient's body.However, they were unable to obtain the procedure type.In this case, even though the device did not fall out of the patient's body, there was a possibility that it might be left behind, so a report must be submitted to the authorities in japan." it was further clarified that "no fragments had fall into the patient's body".There was no report of injury, medical/surgical intervention or extended hospitalization required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: UNIVERSAL PLUS
• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 20126586
• Report Number: 1320894-2024-00222
• Device Sequence Number: 20682379
• Product Code: GEI
• UDI-Device Identifier: 30653405010702
• UDI-Public: (01)30653405010702(17)280401(10)202304031
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K952204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: 60-5274-032
• Device Lot Number: 202304031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic