BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS CARBON DIOXIDE INSUFFLATOR

    MDR report key: 3021505 · Received March 12, 2013

    Report

    Report Number
    8010047-2013-00078
    Event Type
    Injury
    Date Received
    March 12, 2013
    Report Date
    February 21, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    HIF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN MORE INFORMATION REGARDING THE REPORT, BUT WITH NO RESULT. THE OLYMPUS FIELD SERVICE ENGINEER (FSE) WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED WITH A NON-OLYMPUS ELECTROSURGICAL UNIT, BUT NO FURTHER DETAILS WAS PROVIDED. THE FSE WAS REQUESTED FOR ANOTHER IN-SERVICE ON THE USE OF THE SUBJECT DEVICE. THE FSE ADVISED THE USER NOT TO USE THE SUBJECT DEVICE UNTIL THE SECOND IN-SERVICE IS COMPLETED. THE FSE TESTED THE UNIT AND THE UNIT SEEMED TO WORK FINE. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL FOLLOW.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED AND THE PATIENT SUSTAINED A COLON PERFORATION, AND HAD TO UNDERGO A SURGERY TO RECTIFY THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104227 OLYMPUS CARBON DIOXIDE INSUFFLATOR INSUFFLATOR HIF OLYMPUS MEDICAL SYSTEMS CORPORATION UCR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK