BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB

    MDR report key: 7605390 · Received June 15, 2018

    Report

    Report Number
    7605390
    Event Type
    Malfunction
    Date Received
    June 15, 2018
    Date of Event
    March 14, 2018
    Report Date
    May 30, 2018
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING THE STAPLER WHEN IT JAMMED. THE STAPLER STILL HAD 15 STAPLES LEFT. SUTURE TECHNIQUE WAS USED TO COMPLETE THE PROCEDURE. THE PRODUCT HAD PATIENT CONTACT BUT NO PATIENT HARM. STAPLER IS AVAILABLE FOR RETURN TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449275 INSORB STAPLER, SURGICAL GAG INCISIVE SURGICAL, INC. 2030 173901

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR NOT KNOWN.