BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE STERILE HIGH TEMPERATURE ELECTROCAUTERY (HTC) F7244

    MDR report key: 17919645 · Received October 12, 2023

    Report

    Report Number
    3003072803-2023-00003
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    September 9, 2023
    Report Date
    October 10, 2023
    Manufacturer
    FIAB SPA
    Product Code
    GEI
    UDI-DI
    08033695727145
    PMA / PMN Number
    K100333
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN EU (ITALY) NOT IN US. THE PRODUCT REPORTED IN THE INCIDENT, MODEL F7244, IS IDENTICAL TO THE PRODUCT CLEARED FOR THE MARKETING IN US AND THE 510(K) K100333. THE HEALTHCARE FACILITY, REPORTED THAT DURING AN OPERATION TO PUNCTURE A PATIENT'S FINGER NAIL TO DRAIN A SUBUNGUAL HEMATOMA, THE TIP OF THE ELECTROCAUTERY BROKE AND REMAINED STUCK IN THE PATIENT'S FINGER. EVEN IN THE LACK OF DEVICE INVOLVED, THAT WAS THROWN AWAY (MAKING IT IMPOSSIBLE TO CARRY OUT A TECHNICAL INVESTIGATION) IT IS NEVERTHELESS POSSIBLE TO GIVE A CONCLUSIVE ASSESSMENT WITH REASONABLE CERTAINTY EVEN WITHOUT HAVING EXAMINED THE DEVICE INVOLVED, BASED ON THE INFORMATION AVAILABLE IN THE DESCRIPTION OF THE INCIDENT SECTION OF THE USER'S REPORT. THE ELECTROCAUTERY MODEL F7244, HIGH TEMPERATURE AND FINE TIP, IS INDICATED FOR THE CAUTERIZATION OF SMALL VESSELS, IN ALL THOSE PROCEDURES WHERE PRECISE CAUTERIZATION IS NECESSARY. THESE INDICATIONS ARE REPORTED IN THE INSTRUCTIONS FOR USE. FOR THE TYPE OF SURGERY CARRIED OUT "NAIL DRILLING FOR DRAINAGE OF SUBUNGUAL HEMATOMAS", FIAB RECOMMENDS THE USE OF THE MODEL F7288 (NOT CLEARED FOR THE MARKETING IN US, BUT INTENDED FOR EU MARKET ONLY) WITH A LARGER DIAMETER TIP AND THEREFORE CHARACTERIZED BY GREATER RESISTANCE TO MECHANICAL STRESSES THAT MAY OCCUR DURING THE SPECIFIED PROCEDURE. THE F7288 MODEL, WITH MEDIUM TEMPERATURE AND THICK TIP, IS IN FACT INDICATED - AS WELL AS FOR THE CAUTERIZATION OF SMALL VESSELS - ALSO AND SPECIFICALLY FOR NAIL PERFORATION IN THE CASE OF SUBUNGUAL HEMATOMAS. THE CHARACTERISTIC OF THE TIP HAVING A LARGER DIAMETER AND THEREFORE GREATER RESISTANCE IS WHAT MAKES THE F7288 MODEL SUITABLE FOR THE SPECIFIC USE, A CHARACTERISTIC THAT IS NOT FOUNF IN THE TIP OF THE F7244 MODEL. THE F7244 MODEL IS INSTEAD SUITABLE FOR CONTACT WITH "SOFT" TISSUES AND ACTS (IT IS REQUIRED TO ACT) WITHOUT EXERTING PRESSURE OR MECHANICAL ACTION WHICH COULD OTHERWISE BEND THE TIP FILAMENT, ESPECIALLY IN CONDITIONS OF PROLONGED ACTIVATION (NOT RECOMMENDED BY THE IFU) WHEN THE THE METAL MATERIAL OF THE TIP HEATS UP TO 1200°C AND THEREFORE BECOMES "SOFTER", AND IN EXTREME CASES CAN EVEN CAUSE BREAKAGE DUE TO THE COMBINED ACTION OF PROLONGED HEATING AND PRESSURE. THE REPORTED EVENT IS THEREFORE ATTRIBUTED TO IMPROPER USE OF THE F7244 DEVICE MODEL OUTSIDE OF THE RECOMMENDED INDICATIONS IN AN UNSUITABLE PROCEDURE.

    Description of Event or Problem · 0

    DESCRIPTION OF THE REPORTING HEALTHCARE FACILITY FROM THE REPORT DATED 09/26/2023; "THE DEVICE WAS USED TO PIERCE THE FINGERNAIL OF A PATIENT'S RIGHT HAND AND DRAIN THE SUBUNGUAL HEMATOMA. DURING THE NAIL PIERCING PROCEDURE, THE TIP OF THE ELECTROCAUTERY BROKE OFF AND REMAINED LODGED IN THE FINGER OF THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2119125 DISPOSABLE STERILE HIGH TEMPERATURE ELECTROCAUTERY (HTC) F7244 DISPOSABLE STERILE HIGH TEMPERATURE HCT ELECTROCAUTERY WITH FINE TIP GEI FIAB SPA F7244 5281 08033695727145

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Unknown Required Intervention