BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE RETRIEVAL BASKET V

    MDR report key: 18796284 · Received February 28, 2024

    Report

    Report Number
    9614641-2024-00505
    Event Type
    Injury
    Date Received
    February 28, 2024
    Report Date
    August 12, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    LQR
    UDI-DI
    04953170244049
    PMA / PMN Number
    K955063
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE CORRECTION TO THE PREVIOUSLY SUBMITTED SUPPLEMENTAL REPORT WITH INFORMATION INADVERTENTLY LEFT OUT (MANUFACTURE DATE), CORRECTION TO THE PREVIOUS DEVICE EVALUATION RESULTS, AND TO PROVIDE A CORRECTION TO FIELD H6 CONCLUSION CODE. THE SUBJECT DEVICE WAS MANUFACTURED ON NOVEMBER 2022 BASED ON THE PROVIDED 3 DIGIT LOT INFORMATION "2YK". HOWEVER, THE EXACT MANUFACTURE DATE IS UNKNOWN. THE DEVICE WAS EVALUATED BY OLYMPUS. THE OPERATING WIRE HAD BEEN REMOVED FROM THE TUBE SHEATH. THE OPERATING WIRE WAS BROKEN AT APPROXIMATELY 980 MM FROM ITS DISTAL END OF THE BASKET. APPROXIMATELY 900MM OF WIRE WAS MISSING. THE TUBE SHEATH WAS BROKEN AT APPROXIMATELY 1840 MM FROM ITS DISTAL END. THE TUBE SHEATH INSIDE THE PROTECTIVE TUBE OF THE HANDLE SIDE WAS COMPRESSIVELY BUCKLED.

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE MANUFACTURER¿S INVESTIGATION. A DEVICE EVALUATION, A REVIEW OF THE DEVICE HISTORY RECORD (DHR), A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), AS WELL AS A HISTORICAL TRENDING ANALYSIS WERE CONDUCTED DURING THIS INVESTIGATION. THE DEVICE WAS RETURNED, EVALUATED, AND NO ABNORMALITIES WERE NOTED ON THE DEVICE. THE REVIEW OF THE DHR DID NOT FIND ANY ABNORMALITIES OR ANOMALIES IDENTIFIED DURING PRODUCTION. THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE. THE IFU CONTAINS THE FOLLOWING INFORMATION RELATED TO THE FAILURE MODE: ¿- BEFORE USE, THOROUGHLY REVIEW THE INSTRUCTION MANUALS FOR THIS INSTRUMENT AND THE LITHOTRIPTER (BML-110A-1) TO DETERMINE THE PROPER METHOD OF USE. USING THE INSTRUMENT AND LITHOTRIPTOR WITHOUT THOROUGHLY REVIEWING THEIR MANUALS COULD CAUSE PATIENT INJURY. - DO NOT USE THIS INSTRUMENT IF THE TARGET CALCULUS IS FOUND TO BE IMPOSSIBLE TO RETRIEVE THROUGH PREOPERATIVE DIAGNOSIS, INTEROPERATIVE CONTRAST ENHANCING, OR AFTER PAPILLOTOMY/PAPILLARY DILATION. DO NOT USE THIS INSTRUMENT TO GRASP MULTIPLE CALCULI AT ONE TIME. DOING SO MAY MAKE IT IMPOSSIBLE TO REMOVE THE BASKET (WITH CALCULI ENGAGED) FROM THE PATIENT. - USE THIS INSTRUMENT WITH A HOSPITALIZATION PLAN READY AND THE UNDERSTANDING THAT, IF THE CALCULUS IS TOO HARD TO BE CRUSHED BY THE LITHOTRIPTOR (BML-110A-1), THE INSTRUMENT MAY BECOME IRREVERSIBLY DAMAGED AND OPEN SURGERY MAY HAVE TO TAKE PLACE IN ORDER TO REMOVE THE CALCULUS. - WHEN USING THE BML-110A-1 MECHANICAL LITHOTRIPTOR, THERE IS A POSSIBILITY THAT THE BASKET COULD BECOME DAMAGED AS SHOWN IN SECTION10.8, ¿EMERGENCY TREATMENT¿. USE THE BML-110A-1 WITH THE UNDERSTANDING THAT THE BASKET COULD BECOME DAMAGED AND OPEN SURGERY MAY HAVE TO BE PERFORMED. - REPETITION OF CALCULUS RETRIEVAL WILL DEFORM AND/OR DETERIORATE THIS INSTRUMENT. DEFORMATION AND/OR DETERIORATION MAY MAKE IT DIFFICULT TO RETRIEVE A CALCULUS OR COULD CAUSE THE BASKET WITH CALCULUS ENGAGED TO BECOME IMPACTED IN THE BODY. IF CALCULUS RETRIEVAL NEEDS TO BE REPEATED IN A SINGLE CASE, BE SURE TO INSPECT THE ACTION AND THE APPEARANCE BEFORE EACH RETRIEVAL. STOP USE IF ANY ABNORMALITY (E.G., BASKET WIRE IS CUT OR WORN, TUBE SHEATH IS BENT, ETC.) IS DETECTED DURING THE INSPECTION. - WHEN USING THE BML-110A-1, DO NOT WITHDRAW THE TUBE OF THIS INSTRUMENT FROM THE ENDOSCOPE WHILE THE ENDOSCOPE IS INSERTED INTO THE PATIENT BODY. IF THE ENDOSCOPE IS WITHDRAWN FROM THE PATIENT BODY, AFTER THE TUBE OF THIS INSTRUMENT IS WITHDRAWN FROM THE ENDOSCOPE WHICH IS STILL IN THE PATIENT BODY, (I.E., IF THE ENDOSCOPE IS WITHDRAWN FROM THE PATIENT BODY WHILE THE ONLY OPERATION WIRE OF THIS INSTRUMENT IS STILL IN THE ENDOSCOPE), THE FORCEPS ELEVATOR OF THE ENDOSCOPE CONTACTS THE OPERATION WIRE OF THIS INSTRUMENT DURING THE WITHDRAWAL OF THE ENDOSCOPE, AND MAY KINK THE WIRE. THE KINK OF THE OPERATION WIRE MAY MAKE IT IMPOSSIBLE THAT THE DISTAL END OF THE COIL SHEATH OF THE BML-110A-1 IS INSERTED INTO THE PATIENT BODY OVER THE OPERATION WIRE TILL THE DISTAL END REACHES THE TARGET CALCULUS, AND ENABLE THE BML-110A-1 TO FUNCTION. WHEN USING THE BML-110A-1, EITHER WITHDRAW THE TUBE TOGETHER WITH THE ENDOSCOPE FROM THE PATIENT BODY, OR WITHDRAW THE TUBE OF THIS INSTRUMENT FROM THE PATIENT BODY AFTER WITHDRAWING THE ENDOSCOPE FROM THE PATIENT BODY. THEN, INSERT THE COIL SHEATH OF BML-110A-1 INTO THE PATIENT BODY OVER THE OPERATION WIRE OF THIS INSTRUMENT.¿ BASED ON THE RESULTS OF THE INVESTIGATION AS WELL AS THE CONDITION OF THE RETURNED DEVICE, NO DEFINITIVE CONCLUSION COULD BE DETERMINED FOR THE REPORTED FAILURE MODE. HOWEVER, INVESTIGATIONS THINK IT LIKELY THAT THE SIZE, HARDNESS, OR SHAPE OF THE CALCULUS COULD HAVE CAUSED THE BASKET TO EXPERIENCE THE REPORTED FAILURE MODE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE BASKET GOT STUCK IN THE BILE DUCT DURING STONE REMOVAL. THE BASKET BROKE AT THE PULLEY. AFTER SEVERAL DIFFERENT MANEUVERS, THE BASKET WAS RETRIEVED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927075 SINGLE USE RETRIEVAL BASKET V SINGLE USE RETRIEVAL BASKET LQR AOMORI OLYMPUS CO., LTD. FG-V422PR 2YK 04953170244049

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention