BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MSI PRECISION SPECIALTY INSTRUMENTS

    MDR report key: 22511538 · Received July 15, 2025

    Report

    Report Number
    MW5172705
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Report Date
    July 11, 2025
    Manufacturer
    MED SAVER, INC. / PRECISION CARE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WOULD LIKE TO INFORM YOU THAT DURING A CESAREAN SECTION PERFORMED BY DR. (B)(6), A SITUATION AROSE WITH THE (B)(6) SURGICAL TEAM. DURING THE PROCEDURE, DR. (B)(6) STATED THAT HE FELT AN ELECTRIC SHOCK IN HIS HANDS, AS DID DR. (B)(6), WHEN USING THE PRECISION CARE BRAND ELECTROSURGICAL PENCIL LOT 241115. THE PENCIL WAS IMMEDIATELY CHANGED AND THE SURGERY CONTINUED WITHOUT FURTHER COMPLICATIONS. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544070 MSI PRECISION SPECIALTY INSTRUMENTS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MED SAVER, INC. / PRECISION CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown