BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEMI RIGHT FOREIGN BODY FORCEPS

    MDR report key: 285435 · Received July 7, 2000

    Report

    Report Number
    9610773-2000-00025
    Event Type
    Malfunction
    Date Received
    July 7, 2000
    Date of Event
    June 2, 2000
    Report Date
    June 10, 2000
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HCZ
    Report Source
    Manufacturer report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    A HOSP NURSE REPORTED THAT THE JAWS OF THE GRASPING FORCEPS BROKE OFF IN THE PT'S UTERUS DURING A HYSTEROSCOPY PROCEDURE AS A PHYSICIAN ATTEMPTED TO RETRIEVE AN INTRAUTERINE DEVICE. ACCORDING TO THE NURSE, HALF OF THE JAWS WERE RETRIEVED, BUT THE SECOND PIECE COULD NOT BE LOCATED AND THEREFORE REMAINED INSIDE THE PT'S UTERUS. THE NURSE STATED THAT THE PHYSICIAN WAS NOT CONCERNED ABOUT THE MISSING PIECE SINCE HE FELT THAT THERE WAS NO PLACE FOR THE PIECE TO MIGRATE. THE PROCEDURE WAS NOT COMPLETED BECAUSE THE INTRAUTERINE DEVICE WAS SO DEEPLY EMBEDDED INTO THE UTERUS. HOSPITALIZATION WAS NOT REQUIRED NOR WERE ANTIBIOTICS PRESCRIBED AS A RESULT OF THE OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEMI RIGHT FOREIGN BODY FORCEPS HCZ OLYMPUS WINTER & IBE GMBH A4695 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1