BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESECTION SHEATH, 24 FR.

    MDR report key: 14390400 · Received May 13, 2022

    Report

    Report Number
    9610773-2022-00170
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    April 13, 2022
    Report Date
    May 13, 2022
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761020961
    PMA / PMN Number
    K931995
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL 510K IS K931994. THE SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION: BELOW ARE INVESTIGATION FROM THE LEGAL MANUFACTURER: SINCE THE PRODUCT FOR THIS COMPLAINT WAS NOT RETURNED TO MANUFACTURER, THE INVESTIGATION IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER AND THE SBC (SERVICE BUSINESS CENTER) OLYMPUS. THE PRODUCT WAS SOLD ON JANUARY 15, 2019. ANALYSIS: IT WAS REPORTED IN THE EVENT DESCRIPTION THAT THE CERAMIC TIP BROKE OFF IN THE PATIENT AND PARTS FELL INTO THE PATIENT. AS CONFIRMED BY A REPRESENTATIVE FROM OCA (OLYMPUS) , ALL PARTS OF THE CERAMIC TIP WERE REMOVED FROM THE PATIENT. ADDITIONALLY, IT WAS CONFIRMED NO PATIENT INJURY WAS REPORTED. BASED ON THE DESCRIBED DAMAGE PATTERN, IT CAN BE ASSUMED THE INSULATION TIP'S DAMAGE WAS CAUSED BY MECHANICAL THERMAL INFLUENCE. UNFORTUNATELY, IT CANNOT BE DETERMINED WITH CERTAINTY, WHETHER THERE WAS A PREVIOUS DAMAGE ON THE DEVICE OR ANY DAMAGE ON THE CERAMIC INSULATING INSERT WAS CAUSED DURING LAST REPROCESSING OR DURING LAST USAGE. THE IFU ( INSTRUCTION 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. IN THE CASE OF UNCLEAR REMAINS OF FRACTURE FRAGMENTS, OF THE INSULATING INSERT MADE OF CERAMIC, THESE CAN BE LOCALIZED WITH A SUITABLE X-RAY PROCEDURE OR COMPUTER TOMOGRAPHY AND REMOVED, IF NECESSARY. CAUSE: AS FOR THE TECHNICAL CAUSE, IT IS ASSUMED THAT THE DAMAGE OF THE INSULATION MATERIAL OF THE SHEATH WAS CAUSED BY THERMAL MECHANICAL OVERLOAD, IMPROPER HANDLING, MECHANICAL IMPACT LIKE FALL, SHOCK OR SIMILAR STRESS. ALSO NOTE THAT THE CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO WEAR AND TEAR. PLEASE NOTE THAT SIGNS OF FATIGUE OR PRE-DAMAGE, SUCH AS MINUTE CRACKS, ARE OFTEN HARD TO SPOT. IN GENERAL, THE CUSTOMER IS REQUIRED TO CHECK THE FUNCTION OF ALL DEVICES USED PRIOR TO A PROCEDURE. ADDITIONALLY, ACCORDING TO THE IFU, A SUITABLE REPLACEMENT DEVICE MUST BE PROVIDED DURING AN APPLICATION. A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR DEVICE DEVICE A22041A WITH LOT NUMBER 18YW-0164. THERE IS NO NON-CONFORMITY ASSOCIATED WITH THIS DEVICE WITH RESPECT TO THE DESCRIBED ISSUE. THE DHR ( DEVICE HISTORY RECORD ) REVIEW SHOWED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO VALID INSTRUCTIONS AND MET ALL SPECIFICATIONS. ADDITIONAL INFORMATION: PRIOR TO USING MEDICAL DEVICES, PLEASE ENSURE THEY ARE IN PERFECT TECHNICAL CONDITION. SEE ALSO THE WARNINGS IN THE INSTRUCTIONS FOR USE (IFU). BEFORE USE WARNING INFECTION CONTROL RISK: PROPERLY REPROCESS THE PRODUCT BEFORE FIRST AND EACH SUBSEQUENT USE FOLLOWING THE INSTRUCTIONS IN THIS MANUAL AND IN THE SYSTEM GUIDE ENDOSCOPY. IMPROPER AND/OR INCOMPLETE REPROCESSING CAN CAUSE INFECTION OF THE PATIENT AND/OR MEDICAL PERSONNEL. INSPECTION AND TESTING: INSPECTING THE PRODUCT: VISUALLY INSPECT THE PRODUCT. MAKE SURE THAT IT HAS: NO CORROSION. NO DENTS. NO SCRATCHES. CERAMIC INSULATION AT DISTAL END: VISUALLY INSPECT THE CERAMIC INSULATION AT THE SHEATH¿S DISTAL END BEFORE EACH USE. DO NOT USE THE INSTRUMENT IN CASE OF DAMAGE (E.G. CRACKS, FRACTURES). WARNING RISK OF INJURY: IMPACT, FALL, SHOCK OR SIMILAR STRESS CAN DAMAGE THE CERAMIC INSULATION AT THE SHEATH¿S DISTAL END. DAMAGED INSTRUMENTS CAN CAUSE INJURIES TO THE PATIENT AND/OR USER. DO NOT USE THE INSTRUMENT IF DAMAGED. DAMAGED PRODUCT: IF THE PRODUCT IS DAMAGED OR DOES NOT FUNCTION PROPERLY, CONTACT AN OLYMPUS REPRESENTATIVE OR AN AUTHORIZED SERVICE CENTER. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REPRESENTATIVE (REP.) TERRITORY UROLOGY SALES MANAGER REPORTED THAT PARTS OF THE A22041A RESECTION SHEATH AND LENS ( CERAMIC TIP) BROKE OFF INSIDE OF A PATIENT. THE REP. CONFIRMED THAT ALL PIECES OF THE SHEATH WERE REMOVED FROM THE PATIENT. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE. THERE WAS NO PATIENT INFECTION, HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415073 RESECTION SHEATH, 24 FR. ENDOSCOPE SHEATH, REUSABLE HIH OLYMPUS WINTER & IBE GMBH A22041A 18YW-0164 04042761020961

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown