BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35W

    MDR report key: 5036364 · Received August 27, 2015

    Report

    Report Number
    3003898360-2015-00611
    Event Type
    Malfunction
    Date Received
    August 27, 2015
    Date of Event
    July 13, 2015
    Report Date
    August 19, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAG
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE (1) STAPLER FROM CATALOG NUMBER 528235 VISISTAT 35W (B)(4) WAS RECEIVED USED, OPENED WITHOUT ORIGINAL PACKAGE, LOT # WAS NOT CONFIRMED, STAPLER WAS RECEIVED WITH REMAINING STAPLES; TRIGGER COMPONENT WAS RECEIVED WITH STAPLE PRE-ACTIVATED IN THE TIP OF THE CARTRIDGE, STAPLER WAS RECEIVED WITH EXCESS EMBEDDED RESIDUES IN THE CARTRIDGE. FUNCTIONAL INSPECTION: STAPLER WAS FIRED FOR FULL ACTIVATION CYCLE ACCORDING TO THE IFU PRODUCT "THE TRIGGER MUST BE SQUEEZED ALL THE WAY IN" AND STAPLE PRE-ACTIVATED IN THE TIP OF THE CARTRIDGE WAS LOADED, AND CLOSED, HOWEVER STAPLE IS NOT EASY TO RELEASE. ALTHOUGH; FROM THE SAMPLE RECEIVED THE DEFECT WAS OBSERVED DURING VISUAL INSPECTION & FIRST ACTIVATION; THE ROOT CAUSE FOR THIS ISSUE IS CONSIDERED UNKNOWN SINCE THAT THE TRIGGER COMPONENTS WAS RECEIVED PRE-ACTIVATED & IT IS UNKNOWN WHY IT DID NOT COMPLETE THE ACTIVATION CYCLE. IN ADDITION, STAPLER WAS RECEIVED WITH DRY RESIDUES EMBEDDED. AFTER THE SECOND ACTIVATION STAPLES WERE LOADED, CLOSED & RELEASED; THE DEVICE WORKED PROPERLY. THEREFORE AT THIS TIME NO CORRECTIVE ACTIONS WILL BE TAKEN. ALL PRODUCTS ARE 100% TESTED BY MANUFACTURING AND THIS DEFECT WOULD HAVE BEEN DETECTED DURING THE FUNCTIONAL TESTING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE DEVICE SAMPLE HAS BEEN RETURNED BUT THE INVESTIGATION REPORT HAS NOT BEEN SUBMITTED AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE STAPLER WAS JAMMING AND NOT RELEASING THE STAPLES. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE STAPLER WAS JAMMING AND NOT RELEASING THE STAPLES. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568575 VISISTAT 35W STAPLER GAG TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1