BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESECTION SHEATH, 26 FR.

    MDR report key: 18075491 · Received November 6, 2023

    Report

    Report Number
    9610773-2023-03178
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Report Date
    November 6, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761020985
    PMA / PMN Number
    K931994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4:K931994/ K931995. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 2 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS REPAIR CENTER FOR EVALUATION AND THE REPORTED ISSUE WAS CONFIRMED. THE DEVICE EVALUATION FOUND CERAMIC TIP WAS BROKEN OFF. THE CAUSE FOR THE REPORTED ISSUE CANNOT BE DETERMINED. THE MOST LIKELY CAUSES ARE THERMO-MECHANICAL FATIGUE, WEAR AND TEAR, AND OR IMPROPER HANDLING (IMPACT, SHOCK). AS A GENERAL NOTE, CRACKS ON THE INSULATION MATERIAL ARE MOSTLY NOT VISIBLE, MAKING VISUAL INSPECTION DIFFICULT. IN GENERAL, THE END-USER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. TO PREVENT DEVICE DAMAGE AND OR PATIENT INJURY, THE INSTRUCTION FOR USE PROVIDES THE FOLLOWING: ¿ 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. ¿ VISUALLY INSPECT THE PRODUCT. MAKE SURE THAT IT HAS: NO CORROSION, NO DENTS, NO SCRATCHES. ¿ 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). ¿ 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. ¿ IF THE PRODUCT IS DAMAGED OR DOES NOT FUNCTION PROPERLY, CONTACT AN OLYMPUS REPRESENTATIVE OR AN AUTHORIZED SERVICE CENTER. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE RESECTION SHEATH, 26 FR. CERAMIC TIP WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917269 RESECTION SHEATH, 26 FR. ENDOSCOPE SHEATH, REUSABLE HIH OLYMPUS WINTER & IBE GMBH A22042A UNKNOWN 04042761020985

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown