BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFIED RAPTOR GRASPER, DISPOSABLE

    MDR report key: 19449210 · Received June 3, 2024

    Report

    Report Number
    1223422-2024-00019
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    May 13, 2024
    Report Date
    June 3, 2024
    Manufacturer
    MICROLINE SURGICAL INC
    Product Code
    GEI
    UDI-DI
    00811099010104
    PMA / PMN Number
    K981389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED TO MICROLINE SURGICAL, INC., SO NO INVESTIGATION COULD BE CONDUCTED. THEREFORE, THE CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 0

    DURING PROCEDURE FOR PATIENT, WHILE WAS USING LAPAROSCOPIC INSTRUMENT WITH MICROLINE GRASPER TIP INSIDE THE PATIENT'S BODY, ONE OF THE PIECE OF GRASPER TIP CAME OFF. THE PIECE WAS RETRIREVED. THE DEVICE WILL NOT BE SENT BACK TO MICROLINE SURGICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825637 MODIFIED RAPTOR GRASPER, DISPOSABLE RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS, SINGLE-USE GEI MICROLINE SURGICAL INC 3292 00171336 00811099010104

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown