BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRASPER, DOUBLE ACTION

    MDR report key: 24188293 · Received January 27, 2026

    Report

    Report Number
    24188293
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    December 18, 2025
    Report Date
    January 8, 2026
    Manufacturer
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A HYSTEROSCOPY PROCEDURE PERFORMED ON A PATIENT TO EVALUATE THE ENDOMETRIAL CAVITY, A GRASPING FORCEPS' SCREW CAME LOOSE FROM THE INSTRUMENT INSIDE THE UTERUS. PRIOR TO THE PROCEDURE, A TIME-OUT WAS CONDUCTED, AND THE EQUIPMENT UNDERWENT STANDARD QUALITY ASSURANCE CHECKS BEFORE BEING HANDED TO THE PROVIDER. ONCE THE SCREW CAME LOOSE, THE INSTRUMENT WAS PROMPTLY REMOVED, AND A NEW GRASPER WAS SUCCESSFULLY UTILIZED TO RETRIEVE THE SCREW FRAGMENT. AS AN ADDED PRECAUTION, THE PATIENT WAS SENT TO RADIOLOGY FOR IMAGING TO ENSURE NO ADDITIONAL FRAGMENTS REMAINED. IMAGING RESULTS: IMPRESSION: NO RADIOPAQUE FOREIGN BODY AS CLINICALLY QUERIED. NO ACUTE ABNORMALITY WITHIN THE ABDOMEN OR PELVIS. POST PROCEDURE - THE PATIENT HAD A CT PERFORMED - NO ABNORMAL METAL OBJECTS OR ABNORMAL FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250196 GRASPER, DOUBLE ACTION HYSTEROSCOPE (AND ACCESSORIES) HIH NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. 86422436 D1022436

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female