BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD-CUT IRIS SCISSORS SP/SP GEB 11.5CM

    MDR report key: 6197786 · Received December 22, 2016

    Report

    Report Number
    8010168-2016-00005
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Report Date
    December 22, 2016
    Manufacturer
    GEOMED MEDIZIN-TECHNIK GMBH & CO. KG
    Product Code
    HNF
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD, INCLUDING ACCEPTANCE TESTING RESULTS, WAS REVIEWED AND FOUND TO CONFORM TO SPECIFICATIONS. THE DEVICE WAS SUBJECT TO FUNCTION TESTING AND FOUND TO CONFORM TO SPECIFICATIONS. THE DEVICE WAS SUBJECT TO MICROSCOPIC INSPECTION AND NO FRACTURE OF THE TIP WAS OBSERVED. NO FAILURE DETECTED, DEVICE INTACT.

    Description of Event or Problem · 1

    ACCORDING TO THE DEALER, THE INSTRUMENT TIP WAS BROKEN DURING PEDIATRIC SURGERY. X-RAY WAS TAKEN TO CONFIRM NO BROKEN PARTS INSIDE THE PATIENT. NO HARM DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849059 GOLD-CUT IRIS SCISSORS SP/SP GEB 11.5CM SURGICAL SCISSORS HNF GEOMED MEDIZIN-TECHNIK GMBH & CO. KG 297

    Patients

    Seq Age Sex Outcome Treatment
    1