BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR URETERAL ACCESS SHEATH AND DILATORS

    MDR report key: 9546542 · Received January 3, 2020

    Report

    Report Number
    1820334-2020-00050
    Event Type
    Malfunction
    Date Received
    January 3, 2020
    Date of Event
    December 24, 2019
    Report Date
    February 28, 2020
    Manufacturer
    COOK INC
    Product Code
    FED
    UDI-DI
    00827002540378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: ON 24SEP2019, IMS SAPPORO DIGESTIVE CENTER GENERAL HOSPITAL INFORMED COOK OF AN EVENT INVOLVING A FLEXOR URETERAL ACCESS SHEATH AND DILATOR (RPN: 076000-F120035) OF LOT 10110276. DURING THE INCOMING QUALITY INSPECTION AT THE HOSPITAL, A FOREIGN MATTER WHICH APPEARED TO BE A WHITE PLASTIC DEBRIS WAS CONFIRMED INSIDE THE SEALED PACKAGING. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT. THE COMPLAINT DEVICE WAS RETURNED FOR 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. THE COMPLAINANT RETURNED ONE UNOPEN PACKAGE CONTAINING A FLEXOR URETERAL ACCESS SHEATH AND DILATORS FOR INVESTIGATION. VISUAL EXAMINATION OF THE UNOPEN PACKAGE CONFIRMED A PIECE OF WHITE PLASTIC LIKE MATERIAL SEALED INSIDE THE PACKAGE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND ONE NONCONFORMANCE ASSOCIATED WITH LOT 10110276. THIS NONCONFORMANCE IS RELATED TO THE REPORTED FAILURE MODE. DUE TO THE INDIVIDUAL NATURE OF PLACING PRODUCT INTO PACKAGING DURING MANUFACTURING, ONE NONCONFORMANCE DOES NOT INDICATE ADDITIONAL NON CONFORMANCES IN THE LOT. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. BASED ON THE EVIDENCE PRESENTED BY THE SAMPLE, THIS EVENT HAS BEEN CONTRIBUTED TO A PACKAGING EVENT. A VISUAL INSPECTION OF THE RETURNED UNUSED DEVICE WAS FOUND TO HAVE A PIECE OF WHIT E PLASTIC LIKE MATERIAL INSIDE THE PACKAGE. SINCE EVERY PACKAGE IS INSPECTED FOR FOREIGN MATTER, THE OPERATOR WHO INSPECTED THIS PACKAGE HAS BEEN REQUESTED TO BE RETRAINED TO THE CURRENT SPECIFICATION. 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, , 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, A FOREIGN MATTER WHICH APPEARED TO BE WHITE PLASTIC DEBRIS WAS OBSERVED INSIDE THE SEALED PACKAGING OF A FLEXOR URETERAL ACCESS SHEATH AND DILATORS. THE ISSUE WAS DISCOVERED DURING THE INCOMING QUALITY INSPECTION AT THE HOSPITAL. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12347 FLEXOR URETERAL ACCESS SHEATH AND DILATORS FED COOK INC 10110276 00827002540378

    Patients

    Seq Age Sex Outcome Treatment
    1