BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6034396 · Received October 17, 2016

    Report

    Report Number
    9612501-2016-00784
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    July 7, 2016
    Report Date
    September 20, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED, AN EVALUATION OF ONE SUTURING DEVICE OPENED BY THE ACCOUNT WITHOUT THE PACKAGING AND FOUR RELOADS, ONE SEALED AND THREE OPENED BY THE ACCOUNT. THE VISUAL INSPECTION OF THE OPENED SULU NOTED THAT THE NEEDLE WAS DISENGAGED FROM THE SUTURE. THE NEEDLE WAS NOT RECEIVED. NO FRAYING WAS NOTED AT THE END OF THE SUTURE. THREE NEEDLES WERE RECEIVED SEALED IN PACKAGES. EACH OF THE SEALED NEEDLES WAS LOADED ONTO THE SUBJECT INSTRUMENT. EACH NEEDLE WAS FOUND TO FUNCTION PROPERLY WHEN APPLIED THROUGH LAYERS OF TEST MEDIA. PRESSURE WAS EXERTED ON EACH NEEDLE IN ALL DIRECTIONS AND FROM BOTH SIDES OF EACH JAW TO SIMULATE CLINICAL CONDITIONS. EACH NEEDLE WAS LOADED AND UNLOADED ONTO THE INSTRUMENT WITHOUT DIFFICULTY. NO DIFFICULTY WAS EXPERIENCED IN LOADING, UNLOADING, OR TOGGLING EACH NEEDLE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED.

    Additional Manufacturer Narrative · 1

    FTR# (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE ENDO STITCH* 10MM SUTURING DEVICE OPENED BY THE ACCOUNT WITHOUT THE PACKAGING AND FOUR ENDO STITCH* SURGIDAC*2/0 48 GRN DLU SU, ONE SEALED AND THREE OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. THE VISUAL INSPECTION OF THE OPENED SULU NOTED THAT THE NEEDLE WAS DISENGAGED FROM THE SUTURE. THE NEEDLE WAS NOT RECEIVED. NO FRAYING WAS NOTED AT THE END OF THE SUTURE. THREE NEEDLES WERE RECEIVED SEALED IN PACKAGES. EACH OF THE SEALED NEEDLES WAS LOADED ONTO THE SUBJECT INSTRUMENT. EACH NEEDLE WAS FOUND TO FUNCTION PROPERLY WHEN APPLIED THROUGH LAYERS OF TEST MEDIA. PRESSURE WAS EXERTED ON EACH NEEDLE IN ALL DIRECTIONS AND FROM BOTH SIDES OF EACH JAW TO SIMULATE CLINICAL CONDITIONS. EACH NEEDLE WAS LOADED AND UNLOADED ONTO THE INSTRUMENT WITHOUT DIFFICULTY. NO DIFFICULTY WAS EXPERIENCED IN LOADING, UNLOADING, OR TOGGLING EACH NEEDLE. THE MOST PROBABLE ROOT CAUSE FOR THE SECONDARY UNRELATED CONDITION OF NEEDLE DETACHED FROM SUTURE IS THE SUTURE UNDERGOING TENSION. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN ENDOSCOPY INVOLVING THE ABDOMEN THE SCRUB TECH ENCOUNTERED DIFFICULTIES LOADING THE RELOADS INTO THE HANDLE. THE TECH ENDED UP REPOSITIONING THE NEEDLE IN THE CARTRIDGE AND BY JIGGLING THE DEVICE THE TECH WAS FINALLY ABLE TO LOAD THE RELOAD. THE DEVICE WORKED FINE ONCE LOADED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684635 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN 173016 J6D1916X

    Patients

    Seq Age Sex Outcome Treatment
    1