BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNER SHEATH, FOR 26 FR. OUTER SHEATH

    MDR report key: 14280434 · Received May 4, 2022

    Report

    Report Number
    9610773-2022-00157
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    April 5, 2022
    Report Date
    June 10, 2022
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761029339
    PMA / PMN Number
    K931994
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. PMA/510K: K931995. THE OLYMPUS SERVICE CENTER PERFORMED A VISUAL INSPECTION ON THE RECEIVED CONDITION AND DISCOVERED A PORTION OF THE CERAMIC INSULATION AT THE SHEATH'S DISTAL END BROKEN OFF, WHICH WAS NOT RETURNED FOR EVALUATION. THE OLYMPUS SERVICE CENTER ESTIMATES APPROXIMATELY 30 PERCENT OF THE CERAMIC INSULATION IS MISSING; THE REMAINING INSULATION IS STILL INTACT TO THE INSIDE OF THE SHEATH. THE SHEATH HAS MINOR SCRATCHES IN VARIOUS LOCATIONS THROUGHOUT. ADDITIONALLY, THE RELEASE KNOB FUNCTIONS AS INTENDED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2951238-2022-00393.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION AND THE RESULTS OF THE DEVICE HISTORY RECORDS (DHR) REVIEW. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: A2, A3, A4, B5, H6, H10. THE DHR FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER DETERMINED THE PROBABLE CAUSE OF THE FAILURE IS LIKELY DUE TO WEAR AND TEAR, MECHANICAL OVERLOAD, IMPROPER HANDLING, AND/OR MECHANICAL IMPACT. AS STATED IN THE INSTRUCTIONS FOR USE, THE EVENT MAY HAVE BEEN PREVENTED: 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 CENTRE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, DURING AN UNKNOWNS PROCEDURE, THE INNER SHEATH BROKE AND FELL INTO THE PATIENT. IT IS UNKNOWN IF THE PIECE WAS RETRIEVED OR IF IT REMAINS IN THE PATIENT. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: THE CUSTOMER REPORTED AT THE BEGINNING OF A THERAPEUTIC CYSTOSCOPY FOR RESECTION OF A TRANSURETHRAL BLADDER TUMOR, THE INNER SHEATH FELL INTO THE PATIENT. ONE SMALL PIECE OF THE SHEATH WAS NOT FOUND AND REMAINS IN THE PATIENT. THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE AND NO ISSUES WERE IDENTIFIED. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS A TEN MINUTE DELAY IN THE PROCEDURE WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE CUSTOMER RESPONDED UNKNOWN WHEN ASKED ABOUT PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617466 INNER SHEATH, FOR 26 FR. OUTER SHEATH ENDOSCOPE SHEATH, REUSABLE HIH OLYMPUS WINTER & IBE GMBH A22040A 185W-0060 04042761029339

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other