BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EB010, VOYANT 5MM FUSION 37CM, 6/BX

    MDR report key: 7113000 · Received December 13, 2017

    Report

    Report Number
    2027111-2017-02151
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    November 14, 2017
    Report Date
    December 13, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GEI
    UDI-DI
    00607915117856
    PMA / PMN Number
    K141288
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE COMPLAINANT'S EXPERIENCE OF A LOCKED HANDLE. ENGINEERING OBSERVED THAT THE TRIGGER LOCK, A METAL COMPONENT LOCATED AT THE BOTTOM OF THE TRIGGER, WAS BENT. BASED ON THE CONDITION OF THE RETURNED UNIT, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY DEFORMATION OF THE TRIGGER LOCK, WHICH IS USED TO ENGAGE AND DISENGAGE THE TRIGGER FROM THE HANDLE. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION AND EASE OF USE OF ITS PRODUCTS. AS PART OF THIS PROCESS, APPLIED MEDICAL IS CURRENTLY RESEARCHING POSSIBLE COMPONENT ENHANCEMENTS INTENDED TO FURTHER MINIMIZE THE POTENTIAL FOR THIS TYPE OF EVENT TO OCCUR.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: LAPAROSCOPIC SIGMOID RESECTION. TODAY WE USE THE VOYANT BY A LAP. SIGMA. DR. USED THE VOYANT HANDPIECE AT THE PERITONEAL FAT ON THE INTESTINE AND THAN THE HANDPIECES COULD NOT OPEN. BEFORE THE VOYANT WORKS PERFECT AND THERE WAS NO OTHER INSTRUMENTS OR CLIPS NEAR BY. WE CHANGE THE HANDPIECE AND THEN THE SAME. THE NEXT VOYANT HANDPIECE COULD NOT OPEN. THE THIRD HANDPIECE WORK WHIST OUT PROBLEMS AND THE OPERATION GO ON. THIS REPORT IS LINKED TO MEDWATCH # 2027111-2017-02150. THIS REPORT CONCERNS THE SECOND HANDPIECE, WHICH ALSO WOULD NOT OPEN. CONFIRMATION RECEIVED FROM REP BY EMAIL ON (B)(6) 2017 THAT THE ANSWERS TO THE ADDITIONAL QUESTIONS ARE ALSO VALID FOR THIS CER: THE JAWS WERE ON PERITONEAL FATTY TISSUE. WHEN THE INSTRUMENT WOULD NO LONGER OPEN, THE OPERATOR CAREFULLY PULLED. THIS WAS NOT A PROBLEM, AS THE SEALING CYCLE HAD BEEN COMPLETED. THE BLADE WAS NO LONGER ADVANCED, AS THIS STEP HAD ALSO BEEN COMPLETED. THERE WAS NO BLEEDING. THE REP ESTIMATES THAT THE DEVICE HAD BEEN IN USE FOR UNDER HALF AN HOUR. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892905 EB010, VOYANT 5MM FUSION 37CM, 6/BX GEI GEI APPLIED MEDICAL RESOURCES EB010 1295649 00607915117856

    Patients

    Seq Age Sex Outcome Treatment
    1