BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERAL PURPOSE PROBE12FR SOFT, 400 SERIES, 12FR SOFT

    MDR report key: 23943940 · Received January 2, 2026

    Report

    Report Number
    9613793-2025-00018
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    December 19, 2025
    Report Date
    March 2, 2026
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L
    Product Code
    FLL
    UDI-DI
    50749756820924
    PMA / PMN Number
    K200631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "EXPERIENCED DURING AN ANESTHESIA WHEN USED IN ESOPHAGUS THAT IT JUMP FROM 36,4 TO 7 DEGREES CELSIUS. THEY CHANGED PROBE AND THE SAME HAPPENS, THEY CHANGED MONITOR CABLE AND DIFFERENT SOURCE IN THE MONITOR AND IT STILL HAPPENED." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT IT WAS UNAVAILABLE FOR RETURN. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "EXPERIENCED DURING AN ANESTHESIA WHEN USED IN ESOPHAGUS THAT IT JUMP FROM 36,4 TO 7 DEGREES CELSIUS. THEY CHANGED PROBE AND THE SAME HAPPENS, THEY CHANGED MONITOR CABLE AND DIFFERENT SOURCE IN THE MONITOR AND IT STILL HAPPENED." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT IT WAS UNAVAILABLE FOR RETURN. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE LOT AND NO ASSEMBLY ISSUES WERE NOTED. USING SAMPLES RETURNED FROM OTHER SIMILAR COMPLAINTS, FUNCTIONAL AND DIMENSIONAL TESTING WAS CONDUCTED THAT DETERMINED THERE WAS AN INSTABILITY AT THE CONNECTOR SIDE. THROUGH FURTHER INVESTIGATION, IT WAS DETERMINED THAT A CRIMP SET DIFFERED BETWEEN THE OLDER MOLEX MACHINE AND NEW AUTOMATIC MACHINE. BECAUSE OF THIS DIFFERENCE, THERE WAS MORE PRESSURE APPLIED THAT CAUSED THE PIN TO DEFORM IN SOME CASES. IT WAS DETERMINED THAT THIS IS WHAT LED TO THE CONNECTOR INSTABILITY. A COMPLAINT TO SALES RATIO WAS CONDUCTED OVER THE PAST TWO YEARS AND FOUND TO BE 0.02%. ROOT CAUSE: THE ROOT CAUSE OF THE ISSUE WAS THE USE OF FACTORY-INSTALLED CRIMP SETS IN THE AUTOMATIC MACHINES WITH A PRESSING SURFACE WIDTH NARROWER THAN THE PIN WIDTH. THIS DIMENSIONAL INCOMPATIBILITY GENERATED EXCESSIVE LOCALIZED MECHANICAL STRESS DURING CRIMPING, RESULTING IN PIN DEFORMATION, ALTERED ELECTRICAL CONTACT GEOMETRY, AND SUBSEQUENT CONNECTOR INSTABILITY UNDER TEMPERATURE CONDITIONS. IMMEDIATE CORRECTIONS: CONSIDERING THAT THE IDENTIFIED ROOT CAUSE WAS CONNECTOR INSTABILITY CAUSED BY INSUFFICIENT ELECTRICAL CONTACT BETWEEN THE WIRE AND THE PIN, ALL PERSONNEL INVOLVED WERE INSTRUCTED TO INCORPORATE AN ADDITIONAL VERIFICATION STEP DURING FUNCTIONAL TESTING. THIS STEP CONSISTS OF GENTLY MANIPULATING THE CONNECTOR BY MOVING IT SLIGHTLY ONCE IN AN UPWARD AND DOWNWARD DIRECTION AND FROM SIDE TO SIDE, IN ORDER TO DETECT ANY POTENTIAL INTERMITTENT OR UNSTABLE CONDITIONS. ADDITIONALLY, THE SAMPLING PLAN APPLIED BY QUALITY CONTROL WAS ESCALATED FROM NORMAL INSPECTION TO TIGHTENED INSPECTION. AS A RESULT, THE SAMPLE SIZE PER BOX (2,000 UNITS PER BOX) WAS INCREASED FROM 20 UNITS TO 32 UNITS. THIS ADJUSTMENT WAS IMPLEMENTED TO STRENGTHEN DETECTION CAPABILITY, INCREASE PROCESS OVERSIGHT, AND REDUCE THE RISK OF ESCAPING UNSTABLE UNITS DURING THE CONTAINMENT PHASE. CORRECTIVE ACTIONS: THE AUTOMATIC MACHINE MANUFACTURER (KINGSING) AND THE LOCAL TOOL MANUFACTURER (MOTROSA) WERE CONTACTED. A DIMENSIONAL MODIFICATION OF ALL AUTOMATIC MACHINE CRIMP SETS WAS REQUESTED. POST IMPLEMENTATION OF THESE DIMENSIONAL MODIFICATIONS INDICATE A SUBSTANTIAL REDUCTION IN THE INSTABILITY RATES. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THE INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED, "EXPERIENCED DURING AN ANESTHESIA WHEN USED IN ESOPHAGUS THAT IT JUMP FROM 36,4 TO 7 DEGREES CELSIUS. THEY CHANGED PROBE AND THE SAME HAPPENS, THEY CHANGED MONITOR CABLE AND DIFFERENT SOURCE IN THE MONITOR AND IT STILL HAPPENED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4446 GENERAL PURPOSE PROBE12FR SOFT, 400 SERIES, 12FR SOFT CONTINUOUS MEASUREMENT THERMOMETER FLL DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L 81-02S412EU 60401738 50749756820924

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown