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U.S. Department of Health and Human Services

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

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CONSOLIDATED MEDICAL EQUIPMENT 10/CA LAPAROVUE VISIBILITY SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number LAPVUE10
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/20/2020
Event Type  Malfunction  
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 Description

The sales representative reported on behalf of the customer that the lapvue10 was being used during a robotic hernia repair on (b)(6) 2020. The device was placed inside the patient abdomen and a piece of white plastic was noted inside the abdomen. A grasper was used to retrieve the object. There was no reported injury to the patient. There was no report of medical intervention or hospitalization due to this event. The procedure was completed as planned. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

 
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Brand Name10/CA LAPAROVUE VISIBILITY SYSTEM
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
CONSOLIDATED MEDICAL EQUIPMENT
alejandro dumas ave, 11321
complejo industrial chihuahua
chihuahua, 31136
MX 31136
Manufacturer (Section G)
CONSOLIDATED MEDICAL EQUIPMENT
alejandro dumas ave, 11321
complejo industrial chihuahua
chihuahua, 31136
MX 31136
Manufacturer Contact
john berga
11311 concept blvd.
largo, FL 33773
7273995358
MDR Report Key10368187
MDR Text Key201865001
Report Number3007305485-2020-00333
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK150569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation ADMINISTRATOR/SUPERVISOR
Type of Report Initial,Followup
Report Date 10/02/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/05/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberLAPVUE10
Device LOT Number202001224
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/22/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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