BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINI PCNL

    MDR report key: 19536211 · Received June 14, 2024

    Report

    Report Number
    3004595684-2024-00002
    Event Type
    Death
    Date Received
    June 14, 2024
    Date of Event
    February 27, 2024
    Report Date
    June 14, 2024
    Manufacturer
    TROKAMED GMBH
    Product Code
    FED
    UDI-DI
    04251303810926
    PMA / PMN Number
    K200770
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REF. 3: THE HOSPITAL IS NOT PLANNING TO RETURN THE INSTRUMENT TO THE MANUFACTURER.

    Description of Event or Problem · 0

    ON (B)(6) 2024: THE PATIENT WAS TREATED IN HOSPITAL WITH THE OLYMPUS MINI-PCNL TRAY MINI NEPHROSCOPE DUE TO THE FOLLOWING DIAGNOSIS: 4-CM OBSTRUCTIVE LEFT PELVIC STAGHORN CALCULUS WITH CHRONIC HYDRONEPHROSIS AND RENAL CORTICAL THINNING, MULTIPLE NONOBSTRUCTIVE LEFT RENAL CALYCEAL CALCULI, MARGINAL KIDNEY FUNCTION AT 20%. DURING THE PROCEDURE, THE PHYSICIAN RECOGNISED THAT THERE WAS NOT ENOUGH OUTFLOW FROM THE WORKING SHEATH TOGETHER WITH POOR VISUALIZATION, RESULTING IN INCREASED INTRARENAL PRESSURE. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO SWITCH IRRIGATION PORT AND TESTED FOR POSSIBLE CONTINUOUS FLOW, BUT THIS WAS UNSUCCESSFUL. AS A FINAL SOLUTION DURING SURGERY, THE PHYSICIAN HAD TO REMOVE THE NEPHROSCOPE INTERMITTENTLY TO LET THE IRRIGATION DRAIN OUT AND PRESSURE IRIGATION WAS USED. THE SURGERY CONTINUED AND THE STONE WAS BROKEN COMPLETELY WITH A LARGE BORE LASER. THE PHYSICIAN LATER REALIZED THAT HE WAS NO LONGER GETTING FLOW OUT, EVEN WHEN HE REMOVED THE NEPHROSCOPE. HE DECIDED TO PLACE STENTS, STOP THE PROCEDURE, AND PERFORM THE REST OF THE PROCEDURE AT ANOTHER TIME. THE PATIENT DEVELOPED ASCITES AND ABOUT 1 LITER WAS DRAINED A RUPTURE OF THE LOWER KIDNEY AND OOZING WAS VISIBLE ON CT SCAN. AFTER AN ATTEMPT TO STABILIZE THE PATIENT IN THE ICU AN EMERGENCY NEPHRECTOMY WAS PERFORMED. THE FOLLOWING COMPLICATIONS WERE EXPERIENCED: ASCITES, INTRAPERITONEAL FLUID COLLECTION, HYPOXIA, ABDOMINAL COMPARTMENT SYNDROME (LIKELY DUE TO PYELOCALYCEAL INJURY AND FLUID EXTRAVASATION), HEMORRHAGE, DIC, RUPTURE OF RENAL CAPSULE, DISSECTION OF DISTAL AORTA, NECROTIC TRANSVERSE AND DESCENDING COLON, INFRARENAL ABDOMINAL AORTIC ANEURYSM WITHOUT RUPTURE, CRITICAL LIMB ISCHEMIA RLE. ON (B)(6) 2024: ADDITIONAL SURGERY: EXPLORATORY LAPAROTOMY, OPEN LEFT NEPHRECTOMY, SOURCE CONTROL, PACKING AND WOUND VAC. ADDITIONAL SURGERY: RE-EXPLORATORY LAPAROTOMY, TRANSVERSE AND DESCENDING COLON RESECTION, 6 LAPAROTOMY SPONGES PACKED, ABTHERA PLACEMENT, LIJ, TRIALYSIS CATHETER PLACEMENT. ON (B)(6) 2024: ADDITIONAL SURGERY: RE-EXPLORATORY LAPAROTOMY, RIGHT ASCENDING COLOSTOMY, LEFT MUCOUS FISTULA, 6 LAPAROTOMY SPONGES PACKED, ABTHERA PLACEMENT, LAPAROTOMY EXPLORATORY, LEFT OOPHORECTOMY, ADDITIONAL SURGERY: REMOVAL OF RIGHT CHEST TUBE AND PLACEMENT OF NEW RIGHT CHEST TUBE; LEFT BRACHIAL ARTERY THROMBECTOMY, LEFT DISTAL ULNAR ARTERY, THROMBECTOMY, INTRAOPERATIVE LEFT UPPER EXTREMITY ANGIOGRAM, LEFT FOREARM VOLAR FASCIOTOMY, EMBOLECTOMY BRACHIAL ARTERY, BRACHIAL THROMBECTOMY/LEFT LEG FASCIOTOMY/ULNAR THROMBECTOMY/INTRAOPERATIVE CHOLANGIOGRAM, FASCIOTOMY LOWER EXTREMITY. THE FOLLOWING EVENTS OCCURRED: NEPHROLITHOTOMY PERCUTANEOUS, PARENCHYMAL RUPTURE OF BALLOONED UP KIDNEY, ABDOMINAL COMPARTMENT SYNDROME, INJURY OF LUMBAR BRANCHES OF AORTA, LEFT NEPHRECTOMY, HEMORRHAGE, THROMBECTOMY, COLON RESECTION, SEPTIC SHOCK, CARDIAC ARREST. THE CAUSE OF PATIENT'S DEATH ACCORDING TO THE PHYSICIAN (NO AUTOPSY PERFORMED) WAS: CARDIAC ARREST, SEPTIC SHOCK, COLON ISCHEMIA, DIC, HEMORRHAGIC SHOCK, RESPIRATORY FAILURE, KIDNEY STONE, ABDOMINAL COMPARTMENT SYNDROME, DVT, PARENCHYMAL RUPTURE OF THE KIDNEY. THE PATIENT SUBSEQUENTLY DIED ON (B)(6) 2024. THE OLYMPUS MINI-PCNL COMPRISES SEVERAL INSTRUMENTS. OUR CUSTOMER OLYMPUS OPENDED FOUR COMPLAINTS RELATED TO THIS ADVERSE EVENT. TROKAMED IS THE LEGAL MANUFACTURER OF TWO OF THE DEVICES. IT IS CURRENTLY UNCLEAR IF THE TROKAMED DEVICES CONTRIBUTED TO THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168754 MINI PCNL NEPHROSCOPIC SHEATH FED TROKAMED GMBH WA2PS20S 152424 04251303810926

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Death