MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY LAPAROVUE

Catalog Number	LAPVUE10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation; however, photographic evidence has been provided.A root cause cannot be determined, however, based upon the ifu; a possible cause of this event could be that the foam head was extended the beyond distal end of the trocar.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 (b)(4) device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 10 reports, regarding 10 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 the small head vuetip trocar swab for 5 - 8 mm trocars, and the large head vuetip trocar swab for trocars 8 - 12 mm.Grasp handle and push foam head straight into the trocar.Do not release or bend the vuetip trocar swab.On certain trocar models that have a spring-loaded valve, open the valve during insertion or retraction of the vuetip trocar swab.Make sure trocar does not have any sharp edges that can snag the vuetip trocar swab.Do not extend foam head beyond distal end of trocar.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that on 22may25, the lapvue10, laparovue visibility system laparoscopic solutions device was used in a robot assisted laparoscopic surgery with airseal ports and davinci ports and ¿the tip of the cleaning swab came off completely and remained in the port during normal use to clean the port.This has posed a major patient safety risk as it could easily end up in the patient's abdomen if it had not been noticed.It looks like there is far too little adhesive on the swab.¿.The procedure was completed with the use of an alternate vuetip and a delay of 5 minutes.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.

• Brand Name: LAPAROVUE
• Common Device Name: LAPAROVUE
• 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: 22210162
• Report Number: 3007305485-2025-00102
• Device Sequence Number: 8749179
• Product Code: GCJ
• UDI-Device Identifier: 20845854061746
• UDI-Public: (01)20845854061746(17)270404(10)202404044
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K150569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/16/2025

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: LAPVUE10
• Device Lot Number: 202404044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic