MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY 10/CA LAPAROVUE VISIBILITY SYS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model 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	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the device, lapvue10, 10/ca laparovue visibility sys was being used on (b)(6) 2022 during a laparoscopic gastrectomy procedure and ¿a tip of the port cleaner came completely off the stick handle and had to be retrieved with an instrument.¿ the procedure was completed without an alternate device and there was no report of a delay to the procedure.The tampon tip was pulled back out with laparoscopic graspers.This report is being raised on the basis of 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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, lapvue10, 10/ca laparovue visibility sys was being used on 17feb22 during a laparoscopic gastrectomy procedure and ¿a tip of the port cleaner came completely off the stick handle and had to be retrieved with an instrument.¿ the procedure was completed without an alternate device and there was no report of a delay to the procedure.The tampon tip was pulled back out with laparoscopic graspers.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: d2 and fda product code were corrected from lkf to gcj - laparoscope, general & plastic surgery.Reported event is confirmed.Customer event ¿tip of the port cleaner came completely off the stick handle¿ was confirmed based on photographic evidence and device evaluation.A visual inspection was performed, the cleaning sponge was disassembled from the stick handle.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 15 reports, regarding 15 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: grasp handle and push foam head straight into the trocar.Do not release or bend the vuetip® trocar swab.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 10/CA LAPAROVUE VISIBILITY SYS
• 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: 13695201
• Report Number: 3007305485-2022-00030
• Device Sequence Number: 17226966
• Product Code: GCJ
• UDI-Device Identifier: 20845854061746
• UDI-Public: (01)20845854061746(17)230814(10)202008146
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 08/14/2021
• Device Model Number: LAPVUE10
• Device Catalogue Number: LAPVUE10
• Device Lot Number: 202008146
• 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: 02/17/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic