BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8010047-2018-00346

    MDR report key: 7305530 · Received March 1, 2018

    Report

    Report Number
    8010047-2018-00346
    Event Type
    Malfunction
    Date Received
    March 1, 2018
    Date of Event
    January 30, 2018
    Report Date
    March 1, 2018
    PMA / PMN Number
    PK111425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE BENDING SECTION RUBBER OF THE SUBJECT DEVICE AND THE ADHESIVE WERE DAMAGED. IN ADDITION, THE EVALUATION CONFIRMED THAT THE OUTER DIAMETER OF THE INSERTION PORTION OF THE SUBJECT DEVICE WAS LARGER THAN ITS SPECIFICATION DUE TO THE DAMAGE. THE MANUFACTURING RECORD OF THE SUBJECT DEVICE WAS REVIEWED WITHOUT IRREGULARITY RELATED TO THIS EVENT. IT WAS SURMISED THAT THE CLEARANCE BETWEEN THE INSERTION PORTION AND THE PORT OF THE SCOPE WARMER WAS NARROWED DUE TO THE DAMAGE AND THE NARROWED CLEARANCE CAUSED THE REPORTED EVENT. THE CAUSE OF THE DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED, BUT BASED ON THE PAST SIMILAR CASES, THE EXCESSIVE STRESS FROM COMBINED EQUIPMENT SUCH AS TROCAR DURING THE PROCEDURE POSSIBLY CAUSED THE ACCIDENT. THE OPERATION MANUAL HAS ALREADY WARNED; ¿NEVER ANGULATE THE BENDING SECTION IF IT IS INSIDE A TROCAR TUBE. THE BENDING SECTION MAY BE DAMAGED.¿ ¿ WHEN MOVING AND/OR ROTATING THE BENDING SECTION, CONFIRM THE INDEXES OF INSERTION LENGTH. IF THE BENDING SECTION CONTACTS AT THE EDGE OF THE TROCAR TUBE, DAMAGE TO THE BENDING SECTION MAY RESULT.¿ THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE FACILITY COULD NOT PULL OUT THE SUBJECT DEVICE FROM A NON-OLYMPUS SCOPE WARMER(APPLIED MEDICAL) AND HAD TO REPLACE THE SUBJECT DEVICE WITH ANOTHER SCOPE DURING UNSPECIFIED LAPAROSCOPIC SURGERY. THE FACILITY COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Patients

    Seq Age Sex Outcome Treatment
    1