MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY UNIVERSAL PLUS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	60-6010-003
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
The distributor reported on behalf of their customer that the 60-6010-003 multifunction instrument system (straight grip handle) device was being used during an unknown procedure on an unknown date when it was reported was reported ¿depending on the orientation of the cord, the power will turn on automatically without pressing the button.".The procedure was completed with an alternate device.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The distributor reported on behalf of their customer that the 60-6010-003 multifunction instrument system (straight grip handle) device was being used during an unknown procedure on an unknown date when it was reported was reported ¿depending on the orientation of the cord, the power will turn on automatically without pressing the button.".The procedure was completed with an alternate device.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event ¿the power will turn on automatically, despite the button not being pressed¿ was unconfirmed.Examination of the returned used device 60-6010-003 found that when plugged into the system 5000, the device worked as intended.When the buttons were pressed, output was achieved.Testing found that moving the cord around did not affect the device at all, and the device did not turn on without pressing buttons.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 1 device for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised that when not in use, electrosurgical instruments should be placed in a suitable holder or site which will prevent current flow to the patient, surgical drapes or flammable objects, should the electrosurgical generator be accidentally activated.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): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 22553577
• Report Number: 3007305485-2025-00113
• Device Sequence Number: 9529003
• Product Code: GCJ
• UDI-Device Identifier: 30653405011723
• UDI-Public: (01)30653405011723(17)290206(10)202402084
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: 60-6010-003
• Device Lot Number: 202402084
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic