BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SUTURE CAPTURING DEVICE

    MDR report key: 6521792 · Received April 24, 2017

    Report

    Report Number
    MW5069313
    Event Type
    Malfunction
    Date Received
    April 24, 2017
    Date of Event
    April 10, 2017
    Report Date
    April 11, 2017
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BULLET TIP FROM THE CAPIO SUTURE REF #833-124 CAME OFF OF THE SUTURE DEVICE WHILE IT WAS BEING USED ON A VAGINAL PROCEDURE. DURING THE PLACEMENT OF THE STITCH, THE BULLET NEEDLE OF THE CAPIO DEVICE DISLODGED PRESUMABLY IN THE COOPER'S LIGAMENT. THE SURGEON WAS UNABLE TO FIND THE BULLET TIP IN THE PATIENT. CAPIO CL SUTURE DEVICE WAS ALSO INSPECTED BUT THE BULLET WAS NOT FOUND ON THE DEVICE EITHER. THE BULLET IS TOO SMALL TO BE SEEN ON XRAY SO NO XRAY WAS DONE. GIVEN THAT THE BULLET NEEDLE WAS TINY AND IT'S POTENTIAL EFFECT ON THE PATIENT WAS CLINICALLY 0 PERCENT RISK, AND SINCE IT WOULD HAVE BEEN IMPOSSIBLE TO EXPLORE, IDENTIFY, AND RETRIEVE THE NEEDLE FRAGMENT, THE SURGEON MADE THE DECISION TO LEAVE IT IN PLACE. DATES OF USE: (B)(6) 2017. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296970 CAPIO SUTURE CAPTURING DEVICE CAPIO SUTURING DEVICE GCJ BOSTON SCIENTIFIC 74C1600229

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR