BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOSURE XL HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    MDR report key: 4102596 · Received September 12, 2014

    Report

    Report Number
    1222780-2014-00158
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 15, 2014
    Manufacturer
    HOLOGIC
    Product Code
    HIH
    PMA / PMN Number
    K122498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE EXPIRATION DATE IS NOT KNOWN. SERIAL NUMBER OF THE HYSTEROSCOPE NOT PROVIDED BY THE COMPLAINANT. THE DISPOSABLE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE MANUFACTURE DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT ABLE TO BE CONDUCTED FOR THE MYOSURE DISPOSABLE DEVICE AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MYOSURE FOR UTERINE TISSUE REMOVAL PROCEDURE ON (B)(6) 2014, THE PHYSICIAN HAD "VERY LITTLE VISUALIZATION" AND THE FLUID DEFICIT STARTED TO INCREASE. THE PHYSICIAN THEN PERFORMED A LAPAROSCOPY AND IDENTIFIED A "PERFORATION LOCATED ON THE FUNDAL ANTERIOR". THE PERFORATION WAS STITCHED AND THE PATIENT WAS ADMITTED FOR OBSERVATION. NO INTERVENTION WAS REQUIRED DUE TO THE FLUID DEFICIT. THE PATIENT WAS DISCHARGED ON (B)(6) 2014 AND IS "DOING WELL". ON (B)(6) 2014, IT WAS REPORTED THE "INCREASE IN FLUID DEFICIT WAS NOTED ALONG WITH IMPROVEMENT OF VISUALIZATION AT WHICH TIME IT WAS THE PERFORATION WAS FOUND" THE PHYSICIAN "THEN PERFORMED A LAPAROSCOPY WHICH CONFIRMED THE UTERINE PERFORATION IN ADDITION TO A BOWEL INJURY REQUIRING RESECTION AND RE-ANASTOMOSIS. THE PATIENT WAS ADMITTED TO THE HOSPITAL POST-OPERATIVELY AND WAS DISCHARGED AFTER 5 DAYS. SHE IS CURRENTLY DOING WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565126 MYOSURE XL HYSTEROSCOPIC TISSUE REMOVAL SYSTEM UTERINE TISSUE REMOVAL DEVICE HIH HOLOGIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R AQUILEX FLUID CONTROL MANAGEMENT SYSTEM:| MYOSURE CONTROL UNIT: H1803G13D0| SERIAL NO., (B)(4).| MYOSURE HYSTEROSCOPE: SERIAL NO.,UNK