BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEW HUNTER GRASPER TIP REUSABLE

    MDR report key: 6629217 · Received June 9, 2017

    Report

    Report Number
    1223422-2017-00084
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    May 11, 2017
    Report Date
    May 11, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K974066
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS CURRENTLY UNDER INVESTIGATION AT MICROLINE INC.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY SURGICAL PROCEDURE, THE RENEW TIP BROKE, AND FELL INTO A PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE PIECE. THE PROCEDURE AND ANESTHESIA TIME WAS NOT EXTENDED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412867 RENEW HUNTER GRASPER TIP REUSABLE MANUAL DETACHABLE SURGICAL INSTRUMENTS GEI MICROLINE SURGICAL, INC. 3361 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention