BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESECTION SHEATH, 24 FR.

    MDR report key: 13208522 · Received January 10, 2022

    Report

    Report Number
    9610773-2022-00047
    Event Type
    Injury
    Date Received
    January 10, 2022
    Date of Event
    November 15, 2021
    Report Date
    January 10, 2022
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761020961
    PMA / PMN Number
    K931994
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LEGAL MANUFACTURER'S INVESTIGATION HAS BEEN COMPLETED. COMMON DEVICE NAME, PROCODE: RESECTOSCOPE, FJL. PMA/510K: K931995. THE OLYMPUS SERVICE CENTER EVALUATED THE RETURNED DEVICE AND FOUND THE FOLLOWING: BEAK IS BROKEN AND MISSING PIECE FROM TIP AND THE PASSAGE AND LOCKING IS OK. THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH LOT NUMBER 183W-0121. ALL RECORDS INDICATED THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER DETERMINED THE PROBABLE CAUSE OF THE FAILURE IS LIKELY DUE TO THE INSULATION TIP'S DAMAGE CAUSED BY MECHANICAL THERMAL INFLUENCE BASED ON THE DAMAGE PATTERN. IT IS UNKNOWN IF THERE WAS PREVIOUS DAMAGE ON THE DEVICE OR CERAMIC INSULATING INSERT. THE INSTRUCTIONS FOR USE CARRIES A WARNING THAT THE CERAMIC TIP CAN BREAK DUE TO MECHANICAL LOADING OR THERMALLY INDUCED STRAINING. THUS, IT IS THE RESPONSIBILITY OF THE USER TO INSPECT THE INSTRUMENT PRIOR TO EVERY PROCEDURE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, DURING AN UNSPECIFIED PROCEDURE WITH THE SUBJECT DEVICE, THE CERAMIC TIP BROKE INSIDE OF THE PATIENT'S BLADDER. THE PHYSICIAN IS UNCERTAIN IF ALL PIECED WERE RECOVERED. THE CUSTOMER REPORTED THE SUBJECT DEVICE WAS INSPECTED PRIOR TO USE HOWEVER, THE RESULTS OF THE INSPECTION WERE NOT PROVIDED. THE CUSTOMER ALSO STATED THEY ARE UNAWARE OF ANY PATIENT INJURY OR HARM. MULTIPLE ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION. THE CUSTOMER HAS NOT RESPONDED AND THERE IS NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712655 RESECTION SHEATH, 24 FR. HYSTEROSCOPE (AND ACCESSORIES) HIH OLYMPUS WINTER & IBE GMBH A22041A 183W - 0121 04042761020961

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other