BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMO TC HYP.VASCULAR SCISSORS

    MDR report key: 24637218 · Received March 19, 2026

    Report

    Report Number
    3001286223-2026-00003
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Report Date
    March 19, 2026
    Manufacturer
    FEHLING INSTRUMENTS GMBH
    Product Code
    LRW
    UDI-DI
    04058749007251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DAMAGE TO THE SHEARS INDICATES THAT EXCESSIVE FORCE WAS APPLIED. THE DISTRIBUTOR SUSPECTS THAT THE DAMAGE OCCURRED DURING PROCESSING. THE EXACT CIRCUMSTANCES AND THE SERIAL NUMBER IN QUESTION ARE UNCLEAR.

    Description of Event or Problem · 0

    A DISTRIBUTOR INFORMED US THAT A CUSTOMER CLAIMED THAT SOME OF THE DAMAGED SCISSOR BLADES WERE DISCOVERED IN THE OR BUT BEFORE THEY HAD BEEN USED INSIDE THE PATIENT. THE SURGEON DISCOVERED THE DAMAGE ON ONE OF THE SCISSORS (THE DISTRIBUTOR DOESN'T KNOW WHICH ONE) DURING A CASE WHILE THE INSTRUMENT WAS INSIDE THE PATIENT. THE SURGEON INSISTS THAT THE BLADE BROKE INSIDE THE PATIENT. THE SURGEON 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 THE DISTRIBUTOR KNOWS. IT IS SUSPECTED THAT ALL THESE INSTRUMENTS WERE DAMAGED DUE TO IMPROPER HANDLING OUTSIDE OF THE OPERATING ROOM, AND IT WAS SIMPLY UNFORTUNATE TIMING THAT THE DAMAGE WAS NOT DISCOVERED BEFORE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698108 CERAMO TC HYP.VASCULAR SCISSORS SCISSORS LRW FEHLING INSTRUMENTS GMBH BOP-9 04058749007251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown