BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST-SB1 (D)

    MDR report key: 7760800 · Received August 8, 2018

    Report

    Report Number
    8010047-2018-01565
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    July 12, 2018
    Report Date
    March 15, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FED
    PMA / PMN Number
    K071254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTING TO CORRECT "DEVICE PRODUCT CODE".

    Additional Manufacturer Narrative · 1

    OLYMPUS REPRESENTATIVE VISITED THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION INCLUDING THE OUTCOME OF THE PATIENT. HOWEVER, THE USER FACILITY REFUSED TO PROVIDE THE INFORMATION. THE SUBJECT DEVICE WAS NOT BEEN RETURNED TO OMSC. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. THE OPERATION MANUAL HAS ALREADY WARNED; - IF RESISTANCE IS FELT, DO NOT CONTINUE INSERTION OR WITHDRAWAL ANY FURTHER. DOING SO MAY CAUSE PATIENT INJURY, BLEEDING, PERFORATION, AND/OR EQUIPMENT DAMAGE.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY) PROCEDURE USING THE SUBJECT DEVICE, WHICH INTENDED TO PERFORM A METALLIC STENT PLACEMENT FOR STRICTURE IN THE HEPATIC PORTAL REGION OF THE PATIENT, THE INTESTINAL TRACT OF THE PATIENT WAS PERFORATED. THE PATIENT HAD EXPERIENCED A ROUX-EN-Y ANASTOMOSIS PROCEDURE FOLLOWING GASTRIC RESECTION BEFORE THE ERCP PROCEDURE. IN THE EARLY STAGES OF THE PROCEDURE, THE USER FACILITY USED THE SIF-H290S AND AN OLYMPUS SPLINTING TUBE (THE SUBJECT ST-SB1S); HOWEVER, THE SIF-H290S COULD NOT PASS THROUGH THE ANASTOMOTIC REGION, BEING UNABLE TO REACH THE PAPILLA. THEREFORE, THE USER FACILITY REPLACED THEM WITH ANOTHER OLYMPUS SMALL INTESTINAL SCOPE (SIF-Q260) AND AN OLYMPUS SINGLE USE SPLINTING TUBE (ST-SB1), AND INSERTED THE SIF-Q260 AND THE ST-SB1 UP TO THE PAPILLA. AFTER THAT, THE USER FACILITY REMOVED THE SIF-Q260 FROM THE PATIENT AND CUT A PART AT 15 CM FROM THE PROXIMAL SIDE OF THE ST-SB1 WITH SCISSORS, AND THEN TRIED TO INSERT THE SIF-H290S INTO THE ST-SB1. HOWEVER, SINCE THE DISTAL END OF THE ST-SB1 WAS KINKED AT THE INTESTINAL ANASTOMOTIC REGION, THE SIF-H290S COULD NOT BE INSERTED. AFTER FORCIBLY STRAIGHTEN THE KINK, THE USER FACILITY INSERTED THE SIF-H290S INTO THE ST-SB1 AGAIN. WHEN THE SIF-H290S WAS INSERTED THROUGH THE ST-SB1 INTO THE PATIENT, THE USER FACILITY NOTICED BY UNUSUAL ENDOSCOPIC IMAGE THAT THE DISTAL END OF THE SIF-H290S PERFORATED THE INTESTINAL WALL AND CAME INTO THE ABDOMINAL CAVITY. THE USER FACILITY THEN ASPIRATED INTESTINAL FLUIDS LEAKING INTO THE ABDOMINAL CAVITY AS MUCH AS POSSIBLE USING THE SIF-H290S AND PERFORMED AN EMERGENCY CT SCAN FOR THE PATIENT. THE INTENDED PROCEDURE WAS ABORTED. THE USER FACILITY COMMENTED THAT THE PATIENT¿S PERFORATION LIKELY OCCURRED SINCE THEY PUSHED THE KINKED PART OF THE ST-SB1 TOO STRONG WITH THE SIF-H 290 S. THEREFORE, OMSC SUBMIT THE MDR REGARD WITH THE SIF-H290S AND THE ST-SB1. THIS IS A REPORT ON THE ST-SB1 (2 OF 2 REPORTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607258 ST-SB1 (D) SINGLE USE SPLINTING TUBE FED OLYMPUS MEDICAL SYSTEMS CORP. ST-SB1 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other