BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMO TC HYP.VASCULAR SCISSORS

    MDR report key: 22735448 · Received August 7, 2025

    Report

    Report Number
    3001286223-2025-00001
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    December 4, 2024
    Report Date
    August 7, 2025
    Manufacturer
    FEHLING INSTRUMENTS GMBH
    Product Code
    LRW
    UDI-DI
    04058749007237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE HEALTH PROFESSIONAL REPORTED THE PROBLEM 6 MONTHS AFTER THE PROBLEM OCCURED. WE'VE STARTED THE INVESTIGATION IMMEDIATELY AFTER RECEIVING ALL NECESSARY INFORMATION AND TRIED TO SUBMIT THE REPORT VIA ESGNEXTGEN. AS THE SUBMISSION WASN'T SUCCESSFUL, WE'VE CONTACTED THE SUPPORT TEAM AND SENT THE FORM 3500A VIA E-MAIL.

    Description of Event or Problem · 0

    ON (B)(6) 2025 WE RECEIVED A COMPLAINT THAT THE TIPS OF 3 SCISSORS (REF: BOP-7) WERE BROKEN. THE SCISSORS HAVE BEEN USED FOR MORE THAN A YEAR. THE SCISSORS ARE REUSABLE INSTRUMENTS AND NEED TO BE REPROCESSED AFTER EACH USE. THE TIP OF ONE SCISSORS (REF: BOP-7) SEEMS TO BE BROKEN DURING SURGERY, BUT WE DON'T KNOW, WHICH OF THE 3 SCISSORS IS SUBJECT TO THIS REPORT. WE RECEIVED THE FOLLOWING INFORMATION FROM OUR CUSTOMER: THE SURGEON DISCOVERED THE DAMAGE ON ONE OF THE SCISSORS DURING A CASE WHILE THE INSTRUMENT WAS INSIDE THE PATIENT. SHE INSISTS THAT THE BLADE BROKE INSIDE THE PATIENT. SHE PAUSED THE SURGERY AND USED A C-ARM X-RAY MACHINE TO SEARCH FOR THE BLADE FRAGMENT IN THE PATIENT, BUT SHE NEVER FOUND THE FRAGMENT AND THE PATIENT IS STILL ALIVE WITH NO COMPLICATIONS AS FAR AS WE KNOW. ON REQUEST, WE RECEIVED THIS ADDITIONAL INFORMATION FROM OUR CUSTOMER: ASSIST STATES THAT THEY HAD BEEN USING THE SCISSORS THROUGHOUT THE CASE. WHEN THE SURGEON USED THEM TO CUT INTO A CORONARY ARTERY, THE SCISSORS LOOKED INTACT GOING INTO THE ARTERIAL LUMEN. WHEN THE SCISSORS WERE WITHDRAWN, THE TIP WAS MISSING. THE ARTERIAL LUMEN WAS FLUSHED SEVERAL TIMES AND THE SURGICAL AREA INSPECTED. AN X-RAY WAS SUBSEQUENTLY TAKEN. NO FOREIGN BODY WAS DETECTED ON IMAGING. REMARK: AS THE TIP WASN'T FOUND IN THE PATIENT OR IN THE OR, IT COULD HAVE BEEN BROKEN OUTSIDE THE OR. THESE SCISSORS ARE DELICATE AND TIPS MIGHT BREAK DURING REPROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2006689 CERAMO TC HYP.VASCULAR SCISSORS VASCULAR SCISSORS LRW FEHLING INSTRUMENTS GMBH BOP-7 20224691 04058749007237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown