BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRASPING FORCEPS

    MDR report key: 11683698 · Received April 19, 2021

    Report

    Report Number
    8010047-2021-05067
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    March 19, 2021
    Report Date
    April 19, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    OCZ
    PMA / PMN Number
    K955051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED WITH THREE STERILE PACKAGES TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE RETURNED STERILE PACKAGES WERE CHECKED. AS IT WAS POINTED OUT, A BROWN STAIN WAS CONFIRMED ON THREE PACKAGES. NO ABNORMALITIES SUCH AS FOREIGN MATERIAL ADHESION AROUND THE GRASPING SECTION AND THE REPROCESSING PORT WERE OBSERVED. THE SUBJECT DEVICE WAS CHECKED. INVESTIGATION WAS CARRIED OUT BY RUNNING WATER THROUGH THE REPROCESSING PORT USING A SYRINGE. NO FOREIGN MATERIALS RELATED TO THE REPORTED PHENOMENON CAME OUT OF THE REPROCESSING PORT. NO DEFECTS SUCH AS MISSING PARTS WERE CONFIRMED. ALSO, NO ABNORMALITIES THAT COULD LEAD TO THE HEALTH HAZARD WERE OBSERVED. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. THE COMPLAINT OCCURRENCE THAT IS THE SAME PHENOMENON AS THE REPORTED EVENT OR SIMILAR PHENOMENON TO THE REPORTED EVENT THAT RELATED TO THE PRODUCT FAMILY FOR OVER THE PAST YEAR WAS INSPECTED. ONE REPORT WAS CONFIRMED AT ANOTHER FACILITY. THERE WERE NO REPORTS OF THE OCCURRENCE OF THE COMPLAINT ON THE SAME DEVICE AT THE SAME FACILITY THAT IS THE SAME AS THE REPORTED EVENT OR SIMILAR TO THE REPORTED EVENT. SINCE NO ABNORMALITIES THAT COULD LEAD TO THE REPORTED EVENT WERE DETECTED, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. SINCE THE COMPONENT ANALYSIS WAS PERFORMED IN PAST SIMILAR CASES AND CHEMICAL SOLUTIONS AND CLEANING SOLUTIONS WERE DETECTED IN THE FOREIGN MATERIALS, OMSC PRESUMES THAT THE EVENT OCCURRED DUE TO THE FOLLOWING OCCURRENCE MECHANISM. DUE TO INSUFFICIENT CLEANING, LIQUID SUCH AS CLEANING SOLUTIONS OR CHEMICAL SOLUTIONS REMAINED IN THE INSERTION PORTION. LIQUID THAT REMAINED INSIDE OF THE INSERTION PORTION WAS COMING OUT FROM THE DISTAL END OF THE INSERTION PORTION. THIS CAUSED A STAIN ADHESION. DURING AUTOCLAVING, THE ADHERED LIQUID DRIED OUT BY HEAT.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE HEALTH PROFESSIONAL THAT AFTER REPROCESSING THE SUBJECT DEVICE, THE FOLLOWING EVENT OCCURRED. WHEN THE CUSTOMER CHECKED THE DEVICE INSIDE THE STERILE PACKAGE, BROWN STAINS OF 1 CM SQUARE EXUDED FROM THE TIP OF THE GRASPING SECTION, AND THE STERILE PACKAGE TURNED BROWN AROUND THERE. A SIMILAR EVENT OCCURRED EVEN AFTER REPROCESSING REPEATED. IT ALSO OCCURRED ON THE DEVICE THAT IS NOT USED FOR A PATIENT. THERE IS NO PATIENT INJURY REPORTED CURRENTLY. THE BROWN STAINS WERE NOT IN CONTACT WITH THE FACILITY STAFF'S SKIN SINCE THE STAFF WORE PROTECTIVE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588001 GRASPING FORCEPS GRASPING FORCEPS OCZ OLYMPUS MEDICAL SYSTEMS CORP. FG-49L-1 K1127

    Patients

    Seq Age Sex Outcome Treatment
    1