BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST-SB1 (D)

    MDR report key: 8114255 · Received November 29, 2018

    Report

    Report Number
    8010047-2018-02315
    Event Type
    Injury
    Date Received
    November 29, 2018
    Report Date
    March 6, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP(OMSC). OMSC COULD NOT REVIEW THE SERVICE AND MANUFACTURING RECORD BECAUSE THE LOT NUMBER WAS NOT PROVIDED FROM THE FACILITY. THERE WAS NO MALFUNCTION REPORT OF THE SUBJECT DEVICE CONCERNING THE EVENTS. THE EXACT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿TREATMENT RESULT OF ENDOSCOPIC BALLOON DILATION (EBD) FOR INTESTINAL STENOSIS IN CROHN¿S DISEASE¿ THAT WAS MADE IN PUBLIC IN 26TH JAPAN DIGESTIVE DISEASE WEEK. THE LITERATURE REPORTED THE RESULTS AND ACCIDENTAL SYMPTOMS IN 93 PROCEDURES OF EBD, WHICH WAS CONDUCTED AT THE USER FACILITY AND AFFILIATED FACILITY, FOR 29 CROHN DISEASE PATIENTS. IT WAS ALSO REPORTED THAT THE 2 CASES OF ACCIDENTAL SYMPTOM (PERFORATION) OCCURRED IN THE EBD PROCEDURES AND THE PERFORATIONS WERE TREATED WITH UNSPECIFIED SURGERY. OMSC REVIEWED THE DELIVERY HISTORY OF THE ENDOSCOPES AND THE HISTORY REVEALED THAT OLYMPUS SMALL INTESTINAL VIDEOSCOPES (MODEL SIF-H290S, SIF-Q260) AND SINGLE USE SPLINTING TUBE (ST-SB1, ST-SB1S) HAD BEEN DELIVERED TO THE USER FACILITY. OMSC TRIED TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY, BUT ADDITIONAL INFORMATION WAS NOT PROVIDED AT PRESENT. SINCE THERE WAS NO INFORMATION ON THE MODEL OF THE SMALL INTESTINAL VIDEOSCOPE THAT WAS USED IN THE 2 CASES, OMSC IS SUBMITTING TWO MDRS ACCORDING TO THE NUMBER OF REPORTED PERFORATION CASES IN SMALL INTESTINAL VIDEOSCOPE AND TWO MDRS IN SPLINTING TUBE. THIS IS ONE OF TWO REPORTS IN SINGLE USE SPLINTING TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955553 ST-SB1 (D) SINGLE USE SPLINTING TUBE FED OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN (ST-SB1 OR ST-SB1S) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other