BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESECTION SHEATH, 24 FR.

    MDR report key: 16186129 · Received January 17, 2023

    Report

    Report Number
    9610773-2023-00241
    Event Type
    Injury
    Date Received
    January 17, 2023
    Date of Event
    July 7, 2022
    Report Date
    May 15, 2023
    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
    TN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY 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. IN ADDITION, THE REPORTED ISSUE IS ATTRIBUTED TO WEAR AND TEAR OF THE DEVICE. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: ¿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).¿ ¿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 AUTHORISED SERVICE CENTRE.¿ THIS SUPPLEMENTAL REPORT INCLUDES INFORMATION ADDED TO D8. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PREMARKET SUBMISSION NUMBER: K931995. THE LOT NUMBER OF THE DEVICE REFERENCED IN THIS REPORT IS UNKNOWN, AND IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED TO OLYMPUS AT THIS TIME. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS EVENT HAS BEEN REPORTED BY THE IMPORTER ON MDR#: (B)(4).

    Description of Event or Problem · 0

    OLYMPUS CORPORATION OF THE AMERICAS (OCA) RECEIVED A MEDWATCH 5114040, WHICH REPORTED THAT A FOREIGN BODY WAS RETRIEVED FROM THE ANTERIOR PORTION OF THE PROSTATE FOSSA OF THE PATIENT DURING A CYSTOSCOPY WITH BLADDER BIOPSY. THE FOREIGN BODY WAS CONFIRMED TO BE CONSISTENT WITH THE BEAK OF A RESECTOSCOPE. THE PATIENT HAD A PRIOR CYSTOSCOPY WITH TRANSURETHRAL RESECTION OF THE PROSTATE AND BLADDER TUMOR AND IT WAS BELIEVED THAT THE BEAK TIP BROKE OFF OF THE INNER SHEATH OF THE RESECTOSCOPE THAT WAS USED DURING THAT TIME. THERE WERE NO PATIENT COMPLAINTS AND THE FOREIGN BODY WAS AN INCIDENTAL FINDING DURING THE FOLLOW-UP PROCEDURE. THERE WAS NO FURTHER HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425526 RESECTION SHEATH, 24 FR. ENDOSCOPE SHEATH, REUSABLE HIH OLYMPUS WINTER & IBE GMBH A22041A UNKNOWN 04042761020961

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention