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

Catalog Number	60-5274-144
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Codes	Bowel Burn (1756); Burn(s) (1757)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
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 sales representative reported on behalf of the customer that the device, 60-5274-144, laparoscopic electrode with eschar-resistant coating, was being used during a lap anterior resection procedure on 6sep24 when it was reported, ¿i was handed a yellow bag and label containing the universal plus lhook along with the nurising note stating "hook kept arching out causing multiple bowel injury.".There was no report of medical intervention or hospitalization for the patient.Further assessment has been requested; however, to date we have not received any additional information.This report is being raised due to the potential reported injury of bowel during surgery.
Additional Manufacturer Narrative
Examination of returned used device 60-5274-144 found that the l hook did arch out when in use.Also noticed a slight deformity at the end of the tube by the l hook.Examined per print.The root cause cannot be determined, however, based upon evaluation, photos and an adverse event review meeting, the likely cause of this event was that the device was not properly attached, and grounded per ifu instructions during use.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.A two-year review of complaint history revealed there has been a total of one complaint, regarding one device, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised 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.Do not use these or any electrosurgical instrument with a cable that does not make good, secure contact with the electrosurgical adaptor of the instrument or the electrosurgical generator.If in doubt about the compatibility of a cable from another manufacturer, consult your hospital biomedical engineer.The conmed laparoscopic electrosurgical blade series 60-5272 and 60-5274 are for use with the conmed universal plus series 60-6010 electrosurgical suction/irrigation device only.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 60-5274-144, laparoscopic electrode with eschar-resistant coating, was being used during a lap anterior resection procedure on (b)(6) 2024 when it was reported, ¿i was handed a yellow bag and label containing the universal plus l hook along with the nurising note stating "hook kept arching out causing multiple bowel injury.".There was no report of medical intervention or hospitalization for the patient.Further assessment has been requested; however, to date we have not received any additional information.This report is being raised due to the potential reported injury of bowel during surgery.

• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 20723347
• Report Number: 1320894-2024-00392
• Device Sequence Number: 19772487
• Product Code: GEI
• UDI-Device Identifier: 30653405010740
• UDI-Public: (01)30653405010740(17)280405(10)202304071
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K952204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: 60-5274-144
• Device Lot Number: 202304071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic