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)
Date of Event	10/17/2024
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 for trends through the complaint system to assure patient safety.
Event or Problem Description
Conmed japan reported on behalf of a customer that the 60-6010-003, multifunction instrument system (straight grip handle device was used on (b)(6) 2024 in an unnamed procedure, and ¿there was also an incident where the electrical current sound suddenly sounded even though the cut button was not pressed.¿ further assessment found that the device "probably" was "inactive, button was never pressed, and the device started automatically on its own (button was not stuck).No mentioned there was any injury to a patient/user".There was no report of 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.The 60-5274-132, laparoscopic electrode with eschar-resistant coating will be listed as a concomitant device.There are no allegations filed against it.
Additional Manufacturer Narrative
Correction: the lot number was moved from the serial# box to the lot# box in block d.Additional manufacturer narrative: examination of returned used device 60-6010-003 found that it worked as intended.When the cut button was pressed and used, it worked as it should, and when not pressed, it stopped and there was no electrical sound that rang.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.A two-year review of complaint history revealed there has been a total of two reports, regarding two 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.
Event or Problem Description
Conmed japan reported on behalf of a customer that the 60-6010-003, multifunction instrument system (straight grip handle device was used on (b)(6) 2024 in an unnamed procedure, and ¿there was also an incident where the electrical current sound suddenly sounded even though the cut button was not pressed.¿.Further assessment found that the device "probably" was "inactive, button was never pressed, and the device started automatically on its own (button was not stuck).No mentioned there was any injury to a patient/user".There was no report of 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.The 60-5274-132, laparoscopic electrode with eschar-resistant coating will be listed as a concomitant device.There are no allegations filed against it.

• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 20722799
• Report Number: 3007305485-2024-00179
• Device Sequence Number: 15070768
• Product Code: GCJ
• UDI-Device Identifier: 30653405011723
• UDI-Public: (01)30653405011723(17)280606(10)202306084
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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: 60-6010-003
• Device Lot Number: 202306084
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 60-5274-132, LAPAROSCOPIC ELECTRODE.; 60-5274-132, LAPAROSCOPIC ELECTRODE.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic