BEUDAMED
    FDA Recall Open, Classified

    STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF 11272VUE-R CMOS Video Cysto-Urethroscope REF 11272VUEK-R CMOS Video Cysto-Urethroscope C-VIEW KIT

    Recall: Z-1234-2022 · Initiated May 3, 2022

    Recall

    Recall Number
    Z-1234-2022
    Event Number
    90025
    Firm
    Karl Storz Endoscopy
    FEI Number
    3007475226
    Product Code
    FAJ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 3, 2022
    Address
    2151 E Grand Ave, El Segundo, CA, 90245-5017

    Description

    STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF 11272VUE-R CMOS Video Cysto-Urethroscope REF 11272VUEK-R CMOS Video Cysto-Urethroscope C-VIEW KIT

    Reason

    The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue.

    Action

    On April 29, 2022, KARL STORZ sent an "Urgent Medical Device Recall Notice" Letter via UPS and posting to their website "https://urldefense.com/v3/__https://www.karlstorzcustomerupdates.com/wp-content/uploads/2022/04/C-View-Recall-Customer-Notice.pdf__;!!Lw1uGqvHvtJ_psGG2Et-1voSwbo!bg5okg2Sm91SJG6RWtBKXJ258Z4YgfwOv4ZIuU_ZuW_tH2G1X_CNLBZeGB0YWAZEjDZ4j_-Hvlm6xzzWmhKnBU6U10FQtQHO$" informing customers that certain serial numbers of the Flexible Video Cysto-Urethroscope may exhibit temporary loss of image when monopolar electrocautery is activated. Customers who are in possession of the identified scopes should discontinue use of the affected scopes and return them to KARL STORZ for replacement. Customers can confirm that Endoscope is part of the Recall by comparing the serial number to the serial numbers list in the Appendix. In addition, if customers have already returned any affected scope(s) as part of the Reprocessing Methods Recall, they must still complete the enclosed Acknowledgment Form for this recall and return it as soon as possible via the contact information specified on the form. If customer's Acknowledgment Form for the Reprocessing Methods Recall indicated that they have access to an appropriate sterilization method to sterilize the affected flexible endoscopes, then they will be eligible to have their C-View Endoscope(s) replaced by KARL STORZ. If they have not returned their Acknowledgment Form for the Reprocessing Methods Recall or if their Acknowledgement Form indicated that they do not have access to an appropriate sterilization method, then KARL STORZ will not be able to replace their C-View Endoscope(s) at this time. For questions regarding this action, please use the contact information provided below for the recall execution partner, Sedgwick: Telephone: 877-877-0317 Fax: 877-597-9587 E-Mail: [email protected]

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, VA, VT, WA, WI, WV, and WY. The country of Canada.

    Quantity

    401 units