BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 12 DEGREES, 0.3

    MDR report key: 3853334 · Received April 7, 2014

    Report

    Report Number
    9610773-2014-00012
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION; THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED IS UNKNOWN. IF THE SUSPECT MEDICAL DEVICE IS RETURNED FOR EVALUATION OR ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED. OLYMPUS SUBMITS THIS INCIDENT AS A MEDICAL DEVICE REPORT (MDR) IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED HYSTEROSCOPIC TRANSCERVICAL RESECTION OF THE ENDOMETRIUM (TCRE) PROCEDURE, THE LOOP WIRE OF THE SUSPECT MEDICAL DEVICE BROKE OFF AND FELL INSIDE THE PATIENT'S UTERUS. NO FRAGMENTS/PARTS REMAINED INSIDE THE PATIENT AS THEY WERE REPORTEDLY RETRIEVED BY UNKNOWN APPROACH. IT IS UNKNOWN HOW THE INTENDED PROCEDURE WAS COMPLETED BUT THERE WAS NO REPORT ABOUT PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209055 HF-RESECTION ELECTRODE, LOOP, 24 FR., 12 DEGREES, 0.3 STERILE, SINGLE-USE HF-RESECTION ELE FAS OLYMPUS WINTER & IBE GMBH 13038P03L001

    Patients

    Seq Age Sex Outcome Treatment
    1