BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE MECHANICAL LITHOTRIPTOR V

    MDR report key: 16441172 · Received February 26, 2023

    Report

    Report Number
    9614641-2023-00273
    Event Type
    Malfunction
    Date Received
    February 26, 2023
    Date of Event
    January 30, 2023
    Report Date
    June 5, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    LQC
    UDI-DI
    04953170218422
    PMA / PMN Number
    CLASS2-EXMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY. THIS REPORT IS RELATED TO LINKED PATIENT IDENTIFIER (B)(6) AND SUBMITTED MED WATCH 133833.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND THE DEVICE EVALUATION. PLEASE SEE UPDATES TO D8, D9, E4, H3, H4, H6 AND H10. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE INVESTIGATION CONFIRMED THAT THE BASKET WIRE WAS DEFORMED NEAR THE DISTAL END, AN ELEMENT WIRE OF THE BASKET WIRE WAS BROKEN, AND THE COAL WAS MISALIGNED FROM THE DISTAL END OF THE COIL SHEATH. ADDITIONALLY, WHEN THE OPERATING PIPE WAS PUSHED/PULLED, IT WAS UNABLE TO BE MOVED AND THE BASKET COULD NOT BE OPERATED. 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, IT¿S LIKELY THE GALL STONES WERE TEMPORARILY STUCK IN THE BASKET DUE TO VARIOUS FACTORS SUCH AS THE SIZE, HARDNESS OR SHAPE OF THE CALCULUS. AS A RESULT, IT¿S PROBABLE A LOAD BEYOND THE RESISTANCE STRENGTH WAS APPLIED TO THE PRODUCT DURING THE LITHOTRIPSY. THE FINAL ROOT CAUSE OF THIS EVENT WAS UNABLE TO BE IDENTIFIED. THE FOLLOWING IS INCLUDED IN THE INSTRUCTIONS FOR USE: ¿DO NOT USE THIS INSTRUMENT FOR A CALCULUS THAT IS ASSUMED IMPOSSIBLE TO BE CRUSHED BY A LITHOTRIPTOR. THE PIPE OR THE BASKET WIRE MAY BREAK AND PART OF THIS INSTRUMENT MAY REMAIN IN THE BODY. USE THIS INSTRUMENT BY HAVING THE SETTINGS TO SWITCH TO OPEN SURGERY AND THE HOSPITALIZATION PLAN READY IN CASE THE CALCULUS CANNOT BE CRUSHED BY LITHOTRIPTOR BML-110A-1. A LITHOTRIPTOR CANNOT ALWAYS CRUSH ALL CALCULI CAPTURED IN THE BASKET. OPERATION OF THIS INSTRUMENT IS BASED ON THE ASSUMPTION THAT OPEN SURGERY IS POSSIBLE AS AN EMERGENCY MEASURE. IF THE CALCULUS IS TOO HARD, IT IS POSSIBLE THAT THE DAMAGES SHOWN IN CHAPTER 5, ¿EMERGENCY TREATMENT¿ MAY OCCUR. USE THE LITHOTRIPTOR BY CONSIDERING THAT IT MAY LEAD TO DAMAGING THE INSTRUMENT AND THAT OPEN SURGERY MAY HAVE TO TAKE PLACE. THIS INSTRUMENT WILL DEFORM AND/OR DETERIORATE BY PERFORMING LITHOTRIPSY. WHEN LITHOTRIPSY IS REPEATED, IT WILL DEFORM AND/OR DETERIORATE FURTHERMORE. BY SUCH DEFORMATION AND/OR DETERIORATION, CALCULUS MAY NOT BE CRUSHED AND/OR THE INSTRUMENT WITH CALCULUS ENGAGED MAY NOT BE REMOVED FROM THE BODY. IF LITHOTRIPSY IS REQUIRED TO BE REPEATED IN A SINGLE CASE, MAKE SURE TO CHECK EACH TIME THAT NO ABNORMALITY IS FOUND IN ACTION AND/OR APPEARANCE (E.G. BASKET WIRE CUT OR WORN, TUBE SHEATH BENT, NOTABLE COIL SHEATH BENT OR GAP ETC.). STOP USE WHEN ANY ABNORMALITY IS DETECTED. DURING LITHOTRIPSY, KEEP THE PORTION FROM THE COIL SHEATH TO THE BML HANDLE STRAIGHT IN LINE WITH THE SCOPE¿S BIOPSY VALVE, AS MUCH AS POSSIBLE. IF NOT STRAIGHT, THE COIL SHEATH MAY BEND, CALCULUS MAY NOT BE CRUSHED, AND/OR THE INSTRUMENT WITH CALCULUS ENGAGED MAY NOT BE REMOVED FROM THE BODY. DO NOT ROTATE THE BML HANDLE KNOB ABRUPTLY. THIS INSTRUMENT MAY BREAK, AND/OR CALCULUS MAY NOT BE CRUSHED. ALSO, THE INSTRUMENT WITH CALCULUS ENGAGED MAY NOT BE REMOVED FROM THE BODY.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE SINGLE USE MECHANICAL LITHOTRIPTOR V INITIALLY GRASPED THE STONE WITH THE BASKET WELL. WHEN THE BASKET WAS PULLED SHUT USING THE BML (MANUAL BILIARY STONE FRAGMENTER) HANDLE, A SINGLE WIRE BROKE OFF BELOW THE DISTAL TIP AND LOCKED THE BASKET; SUBSEQUENTLY, THE BASKET COULD NOT BE OPENED. AFTER SEVERAL ATTEMPTS, THE BASKET WAS ABLE TO BE OPENED AND THE STONE WAS RELEASED. COMPLETE RETRACTION OF THE BASKET WAS NOT POSSIBLE DUE TO THE COILED WIRE END, AND THE INSTRUMENT WAS REMOVED FROM THE PATIENT. THE ISSUE OCCURRED DURING THE THERAPEUTIC PROCEDURE (STONE FRAGMENTATION ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY - ERCP), AND THE PROCEDURE WAS COMPLETED WITH THREE STONE RETRIEVAL BASKETS AND REPLACEMENT WITH THIS DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1857883 SINGLE USE MECHANICAL LITHOTRIPTOR V SINGLE USE MECHANICAL LITHOTRIPTOR LQC AOMORI OLYMPUS CO., LTD. BML-V442QR-30 BML 23K 04953170218422

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown MAJ-441, TJF DUODENOVIDEOSCOPE