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	06/11/2024
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.H3 other text : device not yet received.
Event or Problem Description
Conmed japan reported on behalf of their customer that the device, 60-6010-003, universal plus straight-button was being used on 11jun24 and ¿unintended output occurred even though no button was pressed.¿.There was no impact/injury to the patient or user.The procedure was completed with an alternate same device.The 60-5274-032, spatula electrod w/stealth er 5mm x 32cm (5/cs) will be listed as a concomitant device and there was no allegation against it.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one 60-6010-003 in unoriginal package.Lot number was verified.Performed a visual inspection, no abnormalities or defects were observed.Performed a functional inspection using the esu system 7550 ((b)(6)), the device didn't function as intended.Upon further investigation of the inside components, evidence of corrosion was marked near the electrical circuit.The cause of the issue appears to be manufacturing related due to bad soldering on the control board.The manufacturing engineer was notified, and operator awareness training was performed.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 (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).Per the instructions for use, the user is advised the following: use lowest possible power settings on the associated electrosurgical unit capable of achieving the desired surgical effect.Activation time should be as short as possible.Make sure the proper electrosurgical ground pad is used, following the manufacturer¿s directions for proper placement and application.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 their customer that the device, 60-6010-003, universal plus straight-button was being used on (b)(6) 2024 and ¿unintended output occurred even though no button was pressed.¿.There was no impact/injury to the patient or user.The procedure was completed with an alternate same device.The 60-5274-032, spatula electrod w/stealth er 5mm x 32cm (5/cs) will be listed as a concomitant device and there was no allegation against it.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 19989882
• Report Number: 3007305485-2024-00117
• Device Sequence Number: 12869967
• Product Code: GCJ
• UDI-Device Identifier: 30653405011723
• UDI-Public: (01)30653405011723(17)280430(10)202305024
• 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): 09/30/2024

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: 202305024
• 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: 07/24/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 60-5274-032, SPATULA ELECTROD.; 60-5274-032, SPATULA ELECTROD.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic