BEUDAMED
    FDA Recall Terminated

    Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.

    Recall: Z-2713-2017 · Initiated January 17, 2017

    Recall

    Recall Number
    Z-2713-2017
    Event Number
    77308
    Firm
    Pentax of America Inc
    FEI Number
    1000080301
    Product Code
    FDT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 17, 2017
    Terminated
    March 8, 2018
    Address
    3 Paragon Dr, Montvale, NJ, 07645-1782

    Description

    Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.

    Reason

    Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing.

    Action

    The firm, Pentax Medical, sent a "FIELD CORRECTION' letter dated January 17, 2017 to their affected customers via USPS Certified Mail. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove any affected product from use; follow product labeling; ensure all reprocessing personnel are knowledgeable and thoroughly trained on the instructions of Use for manual reprocessing of the devices; clean elevator recesses and follow all reprocessing instructions; and complete and return the FIELD CORRECTION RESPONSE FORM via a member of the PENTAX Service Department as part of an on-site-visit or Fax to: QA/RA Department at 201-799-4063 (alternate 201-391-4189) or a pdf copy to [email protected]. The firm will replace any affected product with its current generation model. If you have questions or request further information or assistance contact PENTAX Medical Customer Support at 1-800-431-5880 (8:30AM - 5:00PM, Monday-Friday, EST) or email: [email protected].

    Distribution

    Worldwide Distribution-US (Nationwide) including states of: AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, PR, TN, TX, UT, VA, WA, WI, WV, WY;. and country of: CANADA.

    Quantity

    2,015 (US - 519 (ED-3490TK) and 5 (ED-3270K); OUS - 1,491)