BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THIRD PARTY CONMED VCARE

    MDR report key: 17529975 · Received August 12, 2023

    Report

    Report Number
    MW5136897
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    August 10, 2021
    Report Date
    August 23, 2021
    Manufacturer
    CONMED CORPORATION
    Product Code
    LFK
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE REPORTED EVENT WAS AS FOLLOWS: DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE PATIENT EXPERIENCED A BLEEDING EVENT WHEN THE SURGEON OF RECORD INSERTED A THIRD PARTY "CON-MED V-CARE DEVICE" AND IT PUNCTURED THE INTERNAL AND EXTERNAL ILIAC VEIN. THIS RESULTED IN BLEEDING AND THE PROCEDURE CONVERTED TO OPEN SURGERY. THE PATIENT REQUIRED BLOOD TRANSFUSIONS AND REOPERATIONS, INCLUDING AMPUTATION OF THE PATIENT'S LEFT LEG. THE SITE RISK MANAGER SAID THAT THERE WAS "NO SUSPICION" AND THERE WAS NO ALLEGATION OF A DA VINCI PRODUCT MALFUNCTION. THE SITE RISK MANAGER ATTRIBUTED THE CAUSE OF THE BLEEDING EVENT WITH BLOOD TRANSFUSIONS AND SUBSEQUENT COMPLICATIONS WITH REOPERATIONS TO WHAT WAS DESCRIBED AS "SURGICAL ERROR" WITH USE OF THE THIRD PARTY CON-MED V-CARE DEVICE. (B)(4). 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
    1085583 THIRD PARTY CONMED VCARE CATHETER, FEMORAL LFK CONMED CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown