BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAS VEGAS PLUS BLUE ALUMINUM HANDLE CANNULA

    MDR report key: 4892652 · Received July 1, 2015

    Report

    Report Number
    1718903-2015-00001
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    May 1, 2015
    Report Date
    June 22, 2015
    Manufacturer
    SHIPPERT MEDICAL TECHNOLOGIES CORP.
    Product Code
    GEA
    PMA / PMN Number
    K022852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUBJECTED TO EXTERNAL FORCE TO CAUSE IT TO BREAK. THE MATERIAL OF CONSTRUCTION, STAINLESS STEEL, IS NOT ONLY COMMON TO CANNULAS, BUT IS VERY STRONG. THE CANNULA HAD TO BE FLEXED REPEATEDLY TO BREAK. MAUDE DATABASE WAS EXAMINED FINDING 41 ENTRIES ASSOCIATED WITH "BREAK". NONE INVOLVED A CANNULA. REPEATED ATTEMPTS WERE MADE TO COLLECT MISSING DATA. NURSE AND DOCTOR DO NOT RESPOND TO ALL QUESTIONS AND ARE NOT TIMELY IN RESPONSES.

    Description of Event or Problem · 1

    PATIENT WENT TO ER AFTER ABDOMINOPLASTY WITH LIPOSUCTION BECAUSE OF DIZZINESS. AFTER EVALUATION, ER FOUND BROKEN PIECE OF LIPOSUCTION CANNULA INSIDE THE PATIENT NEAR SURGICAL SITE. ER REPORTED RESULT TO SURGEON WHO REPORTED BROKEN CANNULA TO US. SURGEON DETERMINED THAT THE BROKEN PIECE COULD REMAIN IN THE PATIENT UNTIL PARTIAL HEALING TAKES PLACE (THEREFORE THIS OBSERVATION IS NOT SERIOUS AND WE DO NOT BELIEVE IT IS AN ADVERSE EVENT) AND THE SURGEON WOULD REMOVE A PIECE OF CANNULA IN THE (B)(6) 2015, TIME FRAME. THE CANNULA WAS A RE-USABLE CANNULA THAT HAD BEEN USED AT LEAST FOUR TIMES PRIOR TO THIS BREAK. (B)(4) HAS BEEN DISTRIBUTING THIS TYPE OF CANNULA FOR AT LEAST EIGHT YEARS (OVER (B)(4) CANNULAS) WITHOUT A PROBLEM OF THIS TYPE. AFTER EVALUATION OF THE PIECE THE DOCTOR STILL HAD AND SENT TO US FOR EVALUATION, (B)(4) BELIEVES THE CANNULA BROKE DUE TO AN EVENT DURING THE SURGERY, NOT A WEAKNESS IN THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429354 LAS VEGAS PLUS BLUE ALUMINUM HANDLE CANNULA CANNULA, SURGICAL GEA SHIPPERT MEDICAL TECHNOLOGIES CORP. 3-H-BA-LV+-5X30

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O