BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIAPC PROBE 2200 A W/ FILTER

    MDR report key: 25299454 · Received May 27, 2026

    Report

    Report Number
    9610614-2026-00092
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060183
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REUSED SINGLE USE FIAPC PROBE IS IN THE PROCESS OF BEING RETURNED FOR AN EVALUATION (NOTE: THE INSTRUCTIONS FOR USE EXPLICITLY STATE THAT THE PROBE IS INTENDED FOR SINGLE-USE ONLY AND MUST NOT BE REPROCESSED. PROCESSING CAN AFFECT THE MATERIAL PROPERTIES AND/OR FUNCTION OF THE PRODUCT SUCH THAT APPLICATION IN ACCORDANCE WITH THE INTENDED USE IS NO LONGER POSSIBLE. IT ALSO CANNOT BE ENSURED THAT THE PRODUCT WILL BE STERILE AFTER PROCESSING.). IF THE DEVICE IS RETURNED/INSPECTED AND A CONCLUSIVE DETERMINATION IS MADE AS TO THE CAUSE(S) OF THE EVENT, THEN A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ERBE FIAPC® PROBE WAS INVOLVED IN AN INCIDENT DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD). NO INFORMATION WAS PROVIDED REGARDING THE APC/ESU SYSTEM USED, OR THE EQUIPMENT SETTINGS EMPLOYED DURING THE PROCEDURE. ALSO, WE ARE UNAWARE OF ANY OTHER ACCESSORIES USED DURING THE EGD. PER THE REPORT, THE FIAPC PROBE WAS ACTIVATED, BUT THERE WAS NO TISSUE EFFECT (NOTE: IT WAS REPORTED THAT THE SINGLE USE DEVICE WAS BEING REUSED). UPON REMOVING THE FIAPC PROBE FROM THE SCOPE, THE USER HELD THE ACTIVATED DEVICE BY THE DISTAL END AND SLIGHTLY SHOOK IT. THEN, AN ELECTRIC CURRENT SUDDENLY FLOWED THROUGH THE USER'S HAND, CAUSING AN ELECTRIC SENSATION. THIS RESULTED IN A SLIGHT BURN ON THE USER'S FINGER. NO TREATMENT OR HOSPITALIZATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480545 FIAPC PROBE 2200 A W/ FILTER FIAPC PROBE GEI ERBE ELEKTROMEDIZIN GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Other