MAUDE Adverse Event Report: CONMED UNIVERSAL PLUS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	60-6010-005
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
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 per regulatory requirements to help ensure patient safety.H3 other text: device not yet received.
Event or Problem Description
A sales representative reported on behalf of a customer that the 60-6010-005, multifunction instrument system (straight grip handle) switch device was used in an unnamed procedure on (b)(6) 2026, and ¿buttons on universal plus straight handle got stuck during surgery causing suction to stay on and cause loss of visualization.Patient was not harmed and incident did not affect surgery.Suction irrigation buttons are getting stuck im told when pressing down during case causing suction to remain on and compromise space and visualization.¿.The procedure was completed with the use of an alternate same device and a delay of 1 minute.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
A sales representative reported on behalf of a customer that the 60-6010-005, multifunction instrument system (straight grip handle) switch device was used in an unnamed procedure on (b)(6) 2026, and ¿buttons on universal plus straight handle got stuck during surgery causing suction to stay on and cause loss of visualization.Patient was not harmed and incident did not affect surgery.Suction irrigation buttons are getting stuck im told when pressing down during case causing suction to remain on and compromise space and visualization.¿.The procedure was completed with the use of an alternate same device and a delay of 1 minute.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Update: lot number has been identified, device information has been updated accordingly.Examination of the returned used device 60-6010-005 found that the suction button was stuck in the down position and would not return to the original position of the button.The device was not functionally tested as the customer cut the tube and cord off the device and just returned the handle.Root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be tissue stuck inside the device.A device history record (dhr) review found a non-conformance; however, it was not related to this failure.A two-year lot history review shows a total of 2 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 35 reports, regarding 39 devices, 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).We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: UNIVERSAL PLUS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 24343866
• Report Number: 3007305485-2026-00016
• Device Sequence Number: 10040977
• Product Code: GCJ
• UDI-Device Identifier: 30653405011730
• UDI-Public: (01)30653405011730(17)290502(10)202405034
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K954056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: 60-6010-005
• Device Lot Number: 202405034
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic