BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE DISTAL ATTACHMENT

    MDR report key: 2963054 · Received January 25, 2013

    Report

    Report Number
    8010047-2013-00011
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 26, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN DETAIL INFO. IT WAS REPORTED THAT THE FACILITY CONDUCT EGD USING THE SUBJECT DEVICE AND GASTRO-VIDEOSCOPE FOR BALLOON DILATION 3 DAYS PRIOR TO THE PROCEDURE AND THE DEVICE DETACHED FROM THE ENDOSCOPE. THE FACILITY ALSO REPORTED THAT THEY DID NOT USE MEDICAL TAPE WHEN THE SUBJECT DEVICE WAS ATTACHED TO THE ENDOSCOPE. OMSC COULD NOT EVALUATE THE DEVICE BECAUSE THE DEVICE WAS NOT RETURNED TO OMSC. THERE WERE NO ABNORMALITIES RELATED TO THE PHENOMENON IN THE MFG RECORD OF THE SUBJECT DEVICE. THE DEVICE INSTRUCTION MANUAL INSTRUCTS AS FOLLOWS; "SECURE THE ENDOSCOPE ATTACHMENT SECTION TO THE ENDOSCOPE'S DISTAL END USING LINT-FREE MEDICAL TAPE." THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYS CORP (OMSC) WAS INFORMED THAT DURING AN ESOPHAGEAL GASTROENDOSCOPY (EGD) FOR ESOPHAGEAL DILATION WITH BALLOON CATHETER, THE USER FOUND THAT THE SUBJECT DEVICE HAD BEEN FALLEN INTO THE PT ESOPHAGUS AND THERE WAS A MINOR ULCER IN THE ESOPHAGUS. THE SUBJECT DEVICE WAS REPORTEDLY RETRIEVED WITH AN UNCERTAIN FORCEPS. IN ADDITION, IT WAS REPORTED THAT THE ULCER DID NOT NEED TO BE TREATED AND THERE WAS NO OTHER HARM IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35893 DISPOSABLE DISTAL ATTACHMENT DISTAL ATTACHMENT FOR ENDOSCOPE LFL OLYMPUS MEDICAL SYSTEMS CORPORATION D-201-11804 1YK OR 2XK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK