BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNER SHEATH, FOR 26 FR. OUTER SHEATH, WITH A22085A

    MDR report key: 14497873 · Received May 25, 2022

    Report

    Report Number
    8010047-2022-08867
    Event Type
    Injury
    Date Received
    May 25, 2022
    Report Date
    July 15, 2022
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761029360
    PMA / PMN Number
    K931994
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ADDITIONAL 510K, K931995. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: E2, E3 (CUSTOMER CONTACT DATA UPDATED VIA DILIGENCE).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE PRODUCT FOR THIS EVENT WAS NOT RETURNED FOR EVALUATION/INSPECTION; THEREFORE, THIS INVESTIGATION WAS BASED SOLELY UPON THE INFORMATION PROVIDED BY THE CUSTOMER. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THIS EVENT. IT IS UNCLEAR IF ALL PIECES HAVE BEEN REMOVED FROM THE PATIENT, NOR IS IT KNOWN IF AN ADDITIONAL PROCEDURE WOULD BE REQUIRED TO REMOVE ANY REMAINING FRAGMENTS. HOWEVER, THERE WAS NO REPORT OF ANY PATIENT HARM. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE SUGGESTED PHENOMENON WAS PRESUMED TO HAVE BEEN DUE TO MECHANICAL THERMAL INFLUENCE (THERMAL MECHANICAL OVERLOAD), BASED UPON THE DESCRIBED DAMAGE PATTERN; ALSO, IMPROPER HANDLING, MECHANICAL IMPACT LIKE A FALL, SHOCK, OR SIMILAR STRESS WERE PRESUMED AS FACTORS. FINALLY, WAR AND TEAR WAS ALSO PRESUMED AS A CONTRIBUTING CAUSE OF THE EVENT. HOWEVER, THESE PRESUMED CAUSES CANNOT BE FURTHER DETERMINED - IT IS UNKNOWN WHETHER THERE WAS PREVIOUS DAMAGE ON THE DEVICE OR ANY DAMAGE ON THE CERAMIC INSULATING INSERT THAT MAY HAVE BEEN CAUSED DURING LAST REPROCESSING OR DURING LAST USAGE. THE INSTRUCTIONS FOR USE (IFU) 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE DISASSEMBLED IN THE PATIENT'S CAVITY. IT IS UNKNOWN HOW THE SUBJECT DEVICE WAS RETRIEVED FROM THE PATIENT'S CAVITY OR IF THERE WAS A PROCEDURAL DELAY DUE TO THIS ISSUE. ADDITIONAL INFORMATION IS BEING REQUESTED OF THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392689 INNER SHEATH, FOR 26 FR. OUTER SHEATH, WITH A22085A ENDOSCOPE SHEATH, REUSABLE HIH OLYMPUS WINTER & IBE GMBH A22040T 18YW-0021 04042761029360

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other