BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAPE, ROBOTIC PROCEDURE

    MDR report key: 18282667 · Received December 7, 2023

    Report

    Report Number
    18282667
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    October 20, 2023
    Report Date
    October 20, 2023
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING SURGICAL PROCEDURE, STERILE TEAM MEMBERS NOTED THE POUCH OF THE SURGICAL DRAPE WAS LEAKING ONTO THE FLOOR. SEAM OF THE PLASTIC POUCH APPEARED TO BE WHERE THE LEAK WAS COMING FROM. UNABLE TO DETERMINE IF LEAK WAS ABOVE OR BELOW DRAIN IN DRAPE. DRAPE INFO: (MANUFACTURER #: (B)(6). LOT #: 064736. MFG DATE: [REDACTED DATE]) DRAPE LISTED ON THE PACK AS DRAPE, ROBOTIC PROCEDURE. SURGEON STATED THERE HAD BEEN A SIMILAR LEAK IN AN EARLIER SURGICAL PROCEDURE FIVE DAYS PRIOR. LOT NUMBER NOT AVAILABLE FROM PRIOR CASE. MANUFACTURER NUMBER THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877627 DRAPE, ROBOTIC PROCEDURE DRAPE, SURGICAL KKX 064736

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown