BEUDAMED
    FDA Enforcement Class II Ongoing

    Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery. Product Code: PL771SU

    Recall: Z-1569-2023 · Reported May 17, 2023

    Enforcement

    Recall Number
    Z-1569-2023
    Event ID
    92079
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Aesculap Implant Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 17, 2023
    Initiation Date
    March 21, 2023
    Classification Date
    May 5, 2023
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    Description

    Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery. Product Code: PL771SU

    Reason

    Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body.

    Code Info

    UDI-DI: 04046964837340 Lot Number: 52785146

    Distribution

    US Nationwide distribution in the state of OH.

    Quantity

    6 pieces