BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRASPING FORCEPS

    MDR report key: 7179913 · Received January 10, 2018

    Report

    Report Number
    2951238-2018-00007
    Event Type
    Malfunction
    Date Received
    January 10, 2018
    Report Date
    March 8, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    PTS
    PMA / PMN Number
    PK013591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM EOB TO PTS.

    Additional Manufacturer Narrative · 1

    THE FORCEPS DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE CONFIRMED. A POTENTIAL CAUSE IS OPERATOR¿S TECHNIQUE. THE INSTRUCTION MANUAL HAS WARNINGS AND CAUTIONS FOR AVOIDING DEVICE DAMAGE: ¿NEVER USE EXCESSIVE FORCE TO OPEN OR CLOSE THE GRASPING JAWS. THIS COULD DAMAGE THE INSTRUMENT.¿ ¿DO NOT GRASP OBJECTS OR TISSUE WITH EXCESSIVE FORCE. THE GRASPING JAWS MAY BECOME DAMAGED AND COULD FALL OFF INSIDE THE PATIENT.¿ AND WHEN INSERTING THE DEVICE INTO THE ENDOSCOPE, ¿DO NOT FORCE THE INSTRUMENT IF RESISTANCE TO INSERTION IS ENCOUNTERED. REDUCE THE ANGULATION OF THE ENDOSCOPE UNTIL THE INSTRUMENT PASSES SMOOTHLY. FORCING THE INSTRUMENT COULD DAMAGE THE INSTRUMENT AND/OR ENDOSCOPE.¿ THE INSTRUCTION MANUAL ALSO STATES ¿ALWAYS HAVE A SPARE INSTRUMENT AVAILABLE.¿ AND ¿IF A PART OF THE INSTRUMENT FALLS OFF INSIDE THE PATIENT, USE A SPARE INSTRUMENT TO RETRIEVE IT.¿ THE INSTRUCTION MANUAL ALSO HAS DIRECTIONS FOR PRE-PROCEDURE INSPECTION OF THE FORCEPS DEVICE, INCLUDING FUNCTIONAL VERIFICATION OF GRASPING, AND VISUAL AND TACTILE INSPECTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNKNOWN PROCEDURE, ONE OF THE GRASPING TEETH OF THE FORCEPS DEVICE FELL INSIDE THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY. DESPITE MULTIPLE FOLLOWUP ATTEMPTS WITH THE CUSTOMER, IT IS NOT CURRENTLY KNOWN IF OR HOW THE FRAGMENT WAS RETRIEVED, THE MODEL OF ENDOSCOPE USED WITH THE FORCEPS DEVICE, THE TISSUE INVOLVED, OR IF THE INTENDED PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24457 GRASPING FORCEPS GRASPING FORCEPS PTS OLYMPUS MEDICAL SYSTEMS CORP. FG-53SX-1 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1