BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESECTION SHEATH, 24 FR.

    MDR report key: 16996404 · Received May 24, 2023

    Report

    Report Number
    9610773-2023-01419
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    March 27, 2023
    Report Date
    August 21, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761020961
    PMA / PMN Number
    K931994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    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. BASED ON THE RESULTS OF THE INVESTIGATION, THE DEFINITIVE ROOT CAUSE OF THE CERAMIC TIP DAMAGE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE DAMAGE TO THE CERAMIC BEAK OF THE SHEATH WAS INDUCED BY THERMAL AND MECHANICAL IMPACT, WEAR AND TEAR, IMPROPER HANDLING, OR MECHANICAL OVERLOAD SUCH AS FALL, SHOCK, OR SIMILAR STRESS. THE INSTRUCTION MANUAL IDENTIFIES THE FOLLOWING VERBIAGE, WHICH MAY HAVE PREVENTED THE PHENOMENON: ¿4 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. 4.1 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 FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS REPAIR CENTER FOR EVALUATION. THE DEVICE EVALUATION FOUND THAT THE CERAMIC TIP WAS BROKEN OFF AND THE RUBBER SEAL WAS CRACKED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE RESECTION SHEATH WAS DAMAGED. THE DAMAGE WAS FOUND INSPECTION FOR USE OF AN UNSPECIFIED PROCEDURE. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THE TIP WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970967 RESECTION SHEATH, 24 FR. HYSTEROSCOPE HIH OLYMPUS WINTER & IBE GMBH A22041A 19YW-0018 04042761020961

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown