BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNER SHEATH, FOR 26 FR. OUTER SHEATH

    MDR report key: 14160453 · Received April 20, 2022

    Report

    Report Number
    9610773-2022-00145
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    March 18, 2022
    Report Date
    May 24, 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
    OR, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. LOT NUMBER COULD BE 181-0256 OR 1G1-0256. ADDITIONAL 510K - K931995. 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 2951238-2022-00379.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE CUSTOMER, 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: B5, D4, H4, 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 THERMAL MECHANICAL OVERLOAD, IMPROPER HANDLING, MECHANICAL IMPACT LIKE FALL, SHOCK OR SIMILAR STRESS, AND/OR WEAR AND TEAR. PRIOR TO USING MEDICAL DEVICES, PLEASE ENSURE THEY ARE IN PERFECT TECHNICAL CONDITION. SEE ALSO THE WARNINGS IN THE INSTRUCTIONS FOR USE. 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 THE DISTAL TIP BROKE OFF INTO THE PATIENT DURING A TRANSURETHRAL RESECTION OF THE PROSTATE AT THE BEGINNING OF THE PROCEDURE. CUSTOMER BELIEVES THEY RETRIEVED ALL THE PIECES. DIAGNOSTIC IMAGING WAS TAKEN DURING THE PROCEDURE: X-RAY AND IMAGING CALLED C-ARM WAS BROUGHT INTO THE SURGERY ROOM TO CHECK THE TIP THAT BROKE OFF. THERE WAS A TWENTY-EIGHT MINUTE PROCEDURE DELAY BEFORE THE CASE COULD BEGIN DUE TO RETRIEVAL OF THE BROKEN PIECE AND UNPLANNED DIAGNOSTIC TESTING PERFORMED TO CONFIRM THE PIECE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE CUSTOMER ISN'T SURE IF THEY ARE RETURNING THE DEVICE OR HOLDING ONTO IT TO PERFORM THEIR OWN INVESTIGATION. THE CUSTOMER IS UNSURE OF THE LOT NUMBER AND IT COULD BE 181-0256 OR 1G1-0256. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: THE C-ARM (C-SHAPED IMAGING DEVICE) WAS USED TO LOCATE WHERE THE FRAGMENT WAS AND TO CLEAR THE PATIENT AFTER THE FRAGMENT WAS REMOVED. AN UNKNOWN GRASPER WAS USED TO RETRIEVE THE FRAGMENTS FROM THE BLADDER AND SALINE IRRIGATION FLUID WAS USED TO DRAIN THE BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2719507 INNER SHEATH, FOR 26 FR. OUTER SHEATH INNER SHEATH HIH OLYMPUS WINTER & IBE GMBH A22040A 181W-0256 04042761029339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R