BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAPAROSCOPIC BK PROBE L12C4F

    MDR report key: 17341765 · Received July 18, 2023

    Report

    Report Number
    3003705156-2023-00001
    Event Type
    Injury
    Date Received
    July 18, 2023
    Date of Event
    December 7, 2022
    Report Date
    July 18, 2023
    Manufacturer
    BK MEDICAL APS (PART OF GE HEALTHCARE)
    Product Code
    ITX
    UDI-DI
    05704916000219
    PMA / PMN Number
    K180737
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBE ITSELF WAS EVALUATED AND BK MEDICAL DID NOT FIND EITHER A MANUFACTURING DEFECT OR A MALFUNCTION. THE INVESTIGATION CONCLUDED THAT THERE IS A HIGH LIKELIHOOD THAT THE DAMAGED FLEXIBLE SHEATH IS A RESULT OF MISHANDLING OF THE TRANSDUCER EITHER 1) WHEN STERILIZING THE TRANSDUCER OR 2) WHEN RETRACTING THE TRANSDUCER IN A BEND POSITION OR DUE TO A COMBINATION OF THE TWO POTENTIAL CAUSES. ALL IDENTIFIED RISK SCENARIOS HAVE BEEN ADDRESSED IN THE PRODUCT RISK ASSESSMENT AND BEEN MITIGATED TO AN ACCEPTABLE LEVEL. THE TWO POTENTIAL CAUSES ARE ALREADY ADDRESSED AS CAUTIONS AND WARNINGS IN THE DEVICE USER GUIDE AND USER GUIDE FOR CARE AND CLEANING. THERE IS A LOW RISK OF ANY BIOLOGICAL REACTIONS TO THE PATIENT.

    Description of Event or Problem · 0

    MDR REPORT MW5113739. RECEIVED BY BK MEDICAL 16-DEC-2022. EVENT DESCRIPTION: WHEN INSERTING THE BK MEDICAL LAPAROSCOPIC PROBE THE SHEATH COVERING THE FLEXIBLE TIP TORE AND A PIECE FELL IN PATIENT ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677237 LAPAROSCOPIC BK PROBE L12C4F TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX BK MEDICAL APS (PART OF GE HEALTHCARE) 9066 05704916000219

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other