BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8010047-2018-00571

    MDR report key: 7391463 · Received April 3, 2018

    Report

    Report Number
    8010047-2018-00571
    Event Type
    Malfunction
    Date Received
    April 3, 2018
    Date of Event
    March 6, 2018
    Report Date
    April 3, 2018
    PMA / PMN Number
    PK080948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THERE WAS A MISSING PART IN THE BENDING SECTION RUBBER OF THE SUBJECT DEVICE, SCRATCHES AND CHIPS IN THE ADHESIVE OF THE BENDING SECTION RUBBER. THERE WERE NO OTHER ABNORMALITIES IN THE SUBJECT DEVICE. THE MANUFACTURING RECORD OF THE SUBJECT DEVICE WAS REVIEWED WITHOUT IRREGULARITY RELATED TO THIS EVENT. THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED AT PRESENT; HOWEVER, CONSIDERING THE SIMILAR CASES IN THE PAST, STRONG PHYSICAL STRESS POSSIBLY CAUSED THE DAMAGE. THE OPERATION MANUAL HAS ALREADY WARNED; ¿DO NOT STRIKE, HIT, OR DROP THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION. ALSO, DO NOT BEND, PULL, OR TWIST THE ENDOSCOPE¿SDISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, WITH EXCESSIVE FORCE. THE ENDOSCOPE MAY BE DAMAGED AND COULD CAUSE PATIENT INJURY, BURNS, BLEEDING, AND/OR PERFORATIONS. IT COULD ALSO CAUSE PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.¿ IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE FACILITY NOTICED THAT A PART OF THE BENDING SECTION RUBBER OF THE SUBJECT DEVICE WAS MISSING AT THE END OF A BILLROTH GASTROJEJUNOSTOMY PROCEDURE. THE FACILITY DID NOT KNOW WHEN THE BENDING SECTION RUBBER WAS MISSING. THEY TRIED TO FIND THE PART OF THE BENDING SECTION RUBBER WITHIN THE ABDOMINAL CAVITY, BUT THEY COULD NOT. THE FACILITY CONDUCTED ABDOMINAL IRRIGATION AND COMPLETED THE PROCEDURE WITHOUT REPLACING THE SUBJECT DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR