BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER

    MDR report key: 4352036 · Received December 8, 2014

    Report

    Report Number
    9610617-2014-00065
    Event Type
    Malfunction
    Date Received
    December 8, 2014
    Date of Event
    November 1, 2014
    Report Date
    November 6, 2014
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    GCJ
    PMA / PMN Number
    K935071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE DATA AND INFO CONTAINED HEREIN IS BEING SUBMITTED TO THE FDA TO COMPLY WITH THE REGULATIONS (21 CFR PART 801) PERTAINING TO MEDICAL DEVICE REPORTING. THIS MDR IS BASED ON PRELIMINARY INFO RECEIVED BY KARL STORZ, WHO HAD NOT CONCLUSIVELY DETERMINED THE CAUSE OF THE ADVERSE EVENT. ALLEGEDLY, WHILE PERFORMING A PROCEDURE ONE JAW OF THE BOWEL GRASPER BROKE OFF AND FELL INTO THE PT. THE DOCTOR IMMEDIATELY RETRIEVED THE JAW. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789307 BOWEL GRASPER BOWEL GRASPER GCJ KARL STORZ GMBH & CO. KG 33410C UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention