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

Catalog Number	60-6010-005
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the 60-6010-005 multifunction instrument system (straight grip handle) switch was being used on (b)(6) 2025 and ¿¿button on suction irrigation handpiece #60-6010-005 became "stuck" during surgery today.There was no complications, i also don't know which button specifically was stuck.¿ there was no report of impact or injury to the patient or user.The procedure was completed without an alternate device and the patient status was reported as ¿ok¿.This report is being raised due to the reported 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 per regulatory requirements to help ensure patient safety.H3 other text : device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer that the 60-6010-005 multifunction instrument system (straight grip handle) switch was being used on (b)(6) 2025 and ¿.Button on suction irrigation handpiece #60-6010-005 became "stuck" during surgery today.There was no complications, i also don't know which button specifically was stuck.¿ there was no report of impact or injury to the patient or user.The procedure was completed without an alternate device and the patient status was reported as ¿ok¿.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received (b)(4) 60-6010-005 multifunction instrument system devices, five unused and in unopened original packaging and one used and in opened original packaging.Examination of the returned devices found that the used device had a red suction button that was stuck pressed down and could not be returned to the original upwards position.Note that there was a gap present around the suction button on the used device.Water was also able to flow out of the device when it was held upside down, even when the irrigation button was not engaged.The device was dismantled and the inside of the handle was found to be completely dry.The unused devices worked as intended.The suction and irrigation buttons were able to be pushed down and return to their original upwards position, before and after testing with water involved.The root cause cannot be determined, however, based upon evaluation, non-conformance report and photos, the likely cause of this event was that the device was manufactured outside of parameters.A two-year lot history review shows a total of (b)(4) device for this lot number and failure mode.A device history review (dhr) found a non-conformance related to the reported event.An ncr reviewed by qe (quality engineer) determined that further action is not needed.A two-year review of complaint history revealed there has been a total of (b)(4) reports, regarding (b)(4) 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 23991882
• Report Number: 3007305485-2026-00003
• Device Sequence Number: 10240159
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/12/2026
• 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