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	10/18/2021
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) 2021 during a robotic assisted total gastrectomy procedure and the ¿the sponge came apart when pulling it through a trocar.¿ there was no report of impact or injury to the patient.There was no report of a delay and the procedure was completed.After further assessment, it was discovered all pieces of the device were retrieved with a laparoscopic grasper.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported event of ¿the sponge came apart when pulled through the trocar¿ is inconclusive.The device will not be returned for evaluation and no photographic evidence was provided; therefore, root cause cannot be identified.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.(b)(4).Per the instructions for use, the user is advised the following: grasp the handle and push the 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: 12810968
• Report Number: 3007305485-2021-00411
• Device Sequence Number: 17529847
• Product Code: GCJ
• UDI-Device Identifier: 20845854061746
• UDI-Public: (01)20845854061746(17)220723(10)2021072310
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2021

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 Expiration Date: 07/23/2022
• Device Model Number: LAPVUE10
• Device Catalogue Number: LAPVUE10
• Device Lot Number: 2021072310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic