BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLACH

    MDR report key: 24519095 · Received March 5, 2026

    Report

    Report Number
    1216677-2026-00014
    Event Type
    Injury
    Date Received
    March 5, 2026
    Report Date
    May 1, 2026
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    UDI-DI
    00888937013993
    PMA / PMN Number
    K963653
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: (B)(6) 2024. D4: 909075 OR 909075-05W. DEVICE LOCATION IS UNKNOWN. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    LAW FIRM REPORTED: PATIENT ALLEGEDLY SUFFERED A BURN FROM THE RETURN ELECTRODE PAD WHILE UNDERGOING A LEEP IN (B)(6) 2024. A WALLACH QUANTUM 2000 ELECTROSURGICAL UNIT WAS USED DURING THE PROCEDURE. ACCORDING TO COUNSEL, THE OB/GYN ADMITTED THAT SHE DID NOT USE A "SPLIT OR DUAL" RETURN ELECTRODE AS THE INSTRUCTION MANUAL RECOMMENDS AND AS IS REQUIRED FOR THE SAFETY FEATURE TO FUNCTION. ATTEMPTS HAVE BEEN MADE, BUT NO ADDITIONAL INFORMATION WAS PROVIDED. 909075 QUANTUM 2026-02-0000175.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24712 WALLACH QUANTUM 2000 ELECTROSURGICAL GENERATOR HGI COOPERSURGICAL, INC. 909075 00888937013993

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention