BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESECTION SHEATH, 24 FR.

    MDR report key: 3884141 · Received May 19, 2014

    Report

    Report Number
    9610773-2014-00016
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FJL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICES WERE 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 AS UNKNOWN. HOWEVER, IF THE SUSPECT MEDICAL DEVICES ARE RETURNED FOR EVALUATION OR ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED. THIS REPORT REFERS TO THE SUSPECT MEDICAL DEVICE LABELED AS A22041A IN THE INITIAL REPORT ABOUT THE SAME INCIDENT. CROSS-REFERENCE TO/DUPLICATE OF MFR REPORT NUMBER 9610773-2014-00017, 9610773-2014-00018, 9610773-2014-00019. 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 TRANSURETHRAL RESECTION (TUR) PROCEDURE, THE CERAMIC INSULATION OF THE RESECTION SHEATH (A22041A) BROKE OFF INSIDE THE PATIENT. NO FRAGMENTS/PARTS REMAINED INSIDE THE PATIENT AS THEY WERE REPORTEDLY RETRIEVED BY UNKNOWN APPROACH. THE INTENDED PROCEDURE WAS REPORTEDLY COMPLETED BY USING A SIMILAR DEVICE. THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT HARM OR INJURY. HOWEVER, IT WAS REPORTED THAT THE PATIENT'S LEGS WERE REPEATEDLY TWITCHING DUE TO THE UNINTENDED STIMULATION OF THE OBTURATOR NERVE. FURTHERMORE, AN IDENTICAL PRODUCT PROBLEM/MALFUNCTION REPORTEDLY OCCURRED AGAIN WITH A RESECTION SHEATH OF THE SAME MODEL (A22041A) BUT FROM DIFFERENT LOT DURING ANOTHER SUBSEQUENT PROCEDURE. HOWEVER, NO OTHER INFORMATION WAS PROVIDED FOR THE SECOND INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296104 RESECTION SHEATH, 24 FR. RESECTION SHEATHS FJL OLYMPUS WINTER & IBE GMBH 34W, 92W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other WORKING ELEMENT, ACTIVE (A22060A)| OUTER SHEATH, 27 FR. (A22021A)| HF-RESECTION ELECTRODE, BAND, 24 FR. (A22221C)