BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLING GOULIAN GUARD .004 GAUGE

    MDR report key: 23688883 · Received December 1, 2025

    Report

    Report Number
    3011137372-2025-00416
    Event Type
    Injury
    Date Received
    December 1, 2025
    Date of Event
    November 4, 2025
    Report Date
    November 4, 2025
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    EMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED ONE UNIT OF 050201 GOULIAN GUARD .004 GAUGE LOT Q1 FOR INVESTIGATION. THE RETURNED GUARD WAS VISUALLY EXAMINED WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED GUARD REVEALED THAT THERE APPEARED TO BE NO VISIBLE DEFECTS. THERE WERE NO SIGNS OF BIOLOGICAL MATERIAL ON THE INSTRUMENT. THE CUSTOMER DID NOT RETURN THE BLADE/HANDLE USED WITH THE GUARD. THE GUARD WAS HANDED OFF FOR FUNCTIONAL TESTING AT THE SUPPLIER FACILITY, MSI. UPON FUNCTIONAL TESTING, THE GUARD WAS OBSERVED TO BE A LITTLE LOOSE WHEN ATTACHED TO THE CORRECT SIZED HANDLE. THE LOOSENED GUARD IS CONSISTENT WITH DAMAGE CAUSED BY INSERTING AN INCORRECT HANDLE IN THE GUARD OR CAUSED BY REMOVING THE GUARD FROM THE HANDLE IN A NON-PARALLEL FASHION WHICH SPLAYS OPEN THE TRAILING EDGE OF THE GUARD. THE CUSTOMER REPORTED "ACCORDING TO THE CUSTOMER, THE FIT OF THE GUARD APPEARS TO VARY DEPENDING ON THE ORIENTATION DURING ATTACHMENT SPECIFICALLY, THE GUARD TENDS TO FIT MORE SNUGLY WHEN INSTALLED IN ONE DIRECTION". ACCORDING TO THE CUSTOMER DESCRIPTION, LOOSENESS APPEARED TO BE DEPENDENT ON THE ORIENTATION OF THE GUARD, INDICATING ONE SIDE WAS DAMAGED OR SPLAYED DUE TO IMPROPER REMOVAL OF THE HANDLE. THE ORIGINAL HANDLE USED BY THE CUSTOMER WAS NOT RETURNED; THEREFORE, THE PROBABLE ROOT CAUSE OF THE GUARD'S LOOSENESS COULD NOT BE CONCLUSIVELY TIED TO USER ERROR OR MANUFACTURING WITH THE INFORMATION PROVIDED. THE REPORTED COMPLAINT OF "GUARD SLIPPED BLADE CUT PATIENT'S TISSUE" COULD BE CONFIRMED BASED UPON THE SAMPLE RECEIVED. THE CUSTOMER RETURNED ONE UNIT OF 050201 GOULIAN GUARD .004 GAUGE LOT Q1 FOR INVESTIGATION. THE GUARD WAS HANDED OFF FOR FUNCTIONAL TESTING AT THE SUPPLIER FACILITY, MSI. UPON FUNCTIONAL TESTING, THE GUARD WAS OBSERVED TO BE A LITTLE LOOSE WHEN ATTACHED TO THE CORRECT SIZED HANDLE. THE LOOSENED GUARD IS CONSISTENT WITH DAMAGE CAUSED BY INSERTING AN INCORRECT HANDLE IN THE GUARD OR CAUSED BY REMOVING THE GUARD FROM THE HANDLE IN A NON-PARALLEL FASHION WHICH SPLAYS OPEN THE TRAILING EDGE OF THE GUARD. THE CUSTOMER REPORTED "ACCORDING TO THE CUSTOMER, THE FIT OF THE GUARD APPEARS TO VARY DEPENDING ON THE ORIENTATION DURING ATTACHMENT, SPECIFICALLY, THE GUARD TENDS TO FIT MORE SNUGLY WHEN INSTALLED IN ONE DIRECTION". ACCORDING TO THE CUSTOMER DESCRIPTION LOOSENESS APPEARED TO BE DEPENDENT ON THE ORIENTATION OF THE GUARD, INDICATING ONE SIDE WAS DAMAGED OR SPLAYED DUE TO IMPROPER REMOVAL OF THE HANDLE. THE IFU FOR THIS PRODUCT WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE IFU STATES, "THE ASSEMBLY AND DISASSEMBLY OF THE INSTRUMENT MUST ONLY BE PERFORMED BY PERSONNEL TRAINED TO THE INSTITUTION'S TRAINING REQUIREMENTS. THE INSTRUMENT MUST BE CLEANED, FUNCTIONALLY CHECKED, AND STERILIZED (WHERE APPLICABLE) PRIOR TO EACH USE... MISUSE OR IMPROPER HANDLING MAY RESULT IN DAMAGE, POTENTIALLY RESULTING IN USER OR PATIENT INJURY." AND "IF RESISTANCE IS NOT FELT DURING LOADING OF GUARD, DO NOT USE. REPLACE GUARD.... IF GUARD SHIFTS, EXPOSING PREP BLADE, DO NOT USE. REPLACE GUARD." THE ORIGINAL HANDLE USED BY THE CUSTOMER WAS NOT RETURNED; THEREFORE, THE PROBABLE ROOT CAUSE OF THE GUARD'S LOOSENESS COULD NOT BE CONCLUSIVELY TIED TO USER ERROR OR MANUFACTURING WITH THE INFORMATION PROVIDED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE DEVICE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED ROOT CAUSE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "A GUARD SLIPPED OFF THE HANDLE DURING USE ON A PATIENT, EXPOSING BLADE, RESULTING IN AN UNEXPECTED AND SEVERE LACERATION. ACCORDING TO THE CUSTOMER, THE FIT OF THE GUARD APPEARS TO VARY DEPENDING ON THE ORIENTATION DURING ATTACHMENT-SPECIFICALLY, THE GUARD TENDS TO FIT MORE SNUGLY WHEN INSTALLED IN ONE DIRECTION (E.G., LEFT-HANDED APPLICATION VS. RIGHT-HANDED APPLICATION)." A STITCHED REPAIR OF THE AFFECTED AREA WAS PERFORMED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "A GUARD SLIPPED OFF THE HANDLE DURING USE ON A PATIENT, EXPOSING BLADE, RESULTING IN AN UNEXPECTED AND SEVERE LACERATION. ACCORDING TO THE CUSTOMER, THE FIT OF THE GUARD APPEARS TO VARY DEPENDING ON THE ORIENTATION DURING ATTACHMENT-SPECIFICALLY, THE GUARD TENDS TO FIT MORE SNUGLY WHEN INSTALLED IN ONE DIRECTION (E.G., LEFT-HANDED APPLICATION VS. RIGHT-HANDED APPLICATION)." A STITCHED REPAIR OF THE AFFECTED AREA WAS PERFORMED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566723 PILLING GOULIAN GUARD .004 GAUGE KNIFE, SURGICAL EMF TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NONE REPORTED.| NONE REPORTED.