BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR URETERAL ACCESS SHEATH AND DILATORS

    MDR report key: 9557204 · Received January 7, 2020

    Report

    Report Number
    1820334-2020-00065
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    Date of Event
    December 19, 2019
    Report Date
    March 2, 2020
    Manufacturer
    COOK INC
    Product Code
    FED
    UDI-DI
    00827002548466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION: ON 19DEC2019, TOMS CO., LTD INFORMED COOK OF AN EVENT INVOLVING A FLEXOR URETERAL ACCESS SHEATH AND DILATOR (RPN: 076000-F140045) OF LOT 10062809. THE DISTRIBUTOR FOUND A FOREIGN MATTER INSIDE THE UNOPENED PACKAGE AT THEIR FACILITY. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT. THE COMPLAINT DEVICE WAS RETURNED FOR A MANUFACTURER'S EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT-BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, SPECIFICATIONS, AND QUALITY CONTROL DATA. VISUAL EXAMINATION OF THE UNOPEN PACKAGE CONFIRMED PACKAGE WAS RECEIVED IN A SEALED STATE.NO FOREIGN MATTER WAS VISUALIZED INSIDE THE PACKAGE. THEREFORE, THE INVESTIGATION WAS UNABLE TO LOCATE ANY FOREIGN MATTER. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND TWO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. DUE TO THE INDIVIDUAL NATURE OF PLACING PRODUCT INTO PACKAGING DURING MANUFACTURING, ONE NONCONFORMANCE DOES NOT INDICATE ADDITIONAL NON CONFORMANCES IN THE LOT. ADDITIONALLY, THERE HAVE BEEN NO OTHER COMPLAINTS FILED FOR THIS LOT. THEREFORE, THERE IS NO EVIDENCE TO SUGGEST THAT NONCONFORMING PRODUCT ARE IN THE FIELD; HOWEVER, THIS LOT WILL CONTINUE TO BE MONITORED. THERE IS NO INDICATION THAT A DESIGN PROCESS OR RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS. A CLINICAL ASSESSMENT CONCLUDED THAT A POSSIBLE (BUT NOT LIKELY SINCE NO FOREIGN MATTER WAS OBSERVED IN THE RETURNED SEALED PACKAGE) CONTRIBUTING FACTOR COULD BE MANUFACTURING RELATED. ALTHOUGH, A VISUAL EXAMINATION OF THE RETURNED DEVICE WAS UNABLE TO CONFIRM FOREIGN MATTER INSIDE THE SEALED PACKAGE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). THIS DEVICE IS NOT SOLD IN THE UNITED STATES. THERE ARE SIMILAR DEVICES SOLD IN THE UNITED STATES, FOR EXAMPLE CATALOG NUMBER FUS-095020. INFORMATION FOR FUS-095020: COMMON DEVICE NAME: FED ENDOSCOPIC ACCESS OVERTUBE/GASTROENTEROLOGY-UROLOGY, PRODUCT CODE: FED, AND PMA/510(K) # K172217. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTRIBUTOR FOUND A FOREIGN MATTER OF UNKNOWN ORIGIN IN AN UNOPENED PACKAGE OF A FLEXOR URETERAL ACCESS SHEATH AND DILATORS. THIS WAS DISCOVERED BY THE DISTRIBUTOR SO THERE WERE NO ADVERSE EFFECTS TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24831 FLEXOR URETERAL ACCESS SHEATH AND DILATORS FED COOK INC 10062809 00827002548466

    Patients

    Seq Age Sex Outcome Treatment
    1