BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA SOFT URETERAL STENT SET

    MDR report key: 8285329 · Received January 29, 2019

    Report

    Report Number
    1820334-2019-00208
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    January 17, 2019
    Report Date
    February 28, 2019
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002499423
    PMA / PMN Number
    K151051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ 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, THE INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. THE CUSTOMER RETURNED ONE USH-626 STENT FOR INVESTIGATION. VISUAL EXAMINATION CONFIRMED A TEAR IN THE MATERIAL ON THE PROXIMAL COIL. CLOSER EXAMINATION REVEALED THE TEAR ORIGINATED AT THE LAST SIDE PORT MEASURING 1CM LONG. THE TEAR CONTINUES THROUGH END OF THE COIL END. NO OTHER DAMAGE WAS FOUND ON THE STENT. THE RETURNED DEVICE DID NOT DISPLAY ANY MANUFACTURING ANOMALIES. THE EVIDENCE SUGGESTS THE STENT WAS TORN DURING TETHER REMOVAL. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND THERE WERE NO NON-CONFORMANCES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE MODE. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING AND QUALITY CONTROL ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. THE DEVICE HISTORY FILE WAS REVIEWED AND THERE WERE NO ANOMALIES IDENTIFIED THAT WERE RELATED TO THE COMPLAINT FAILURE MODE. NO OTHER COMPLAINTS HAVE BEEN REPORTED ON THE COMPLAINT DEVICE LOT # 9078106. THE UNIVERSA SOFT URETERAL STENT SET IS SUPPLIED WITH INSTRUCTIONS FOR USE (IFU) WHICH STATES: STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE LOCATION OF THE TEAR STARTING AT THE SAME LOCATION AS THE STENT TETHER, IT IS POSSIBLE THAT WHEN THE TETHER WAS REMOVED THE STENT WAS TORN. A DEFINITIVE CONCLUSION COULD NOT BE ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND 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 EVENT INFORMATION HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    OCCUPATION: OTHER HEALTHCARE PROFESSIONAL. PMA/510K: # K151051 (B)(4). 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 WHILE PREPARING TO PERFORM A CYSTOSCOPE URETERAL STENT IMPLANT USING A UNIVERSA SOFT URETERAL STENT SET, THE STENT PACKAGE WAS OPENED AND THE PHYSICIAN FOUND THAT THE STENT HAD A CRACK IN IT. THE FACILITY WILL NOT PROVIDE ANY FURTHER PATIENT INFORMATION DUE TO THEIR PRIVACY POLICIES. THE DEVICE WILL BE RETURNED FOR EVALUATION. THE COMPLAINT DEVICE WAS NOT USED. THE PHYSICIAN USED AN ADDITIONAL NON-SPECIFIED DEVICE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80776 UNIVERSA SOFT URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC G49942 9078106 00827002499423

    Patients

    Seq Age Sex Outcome Treatment
    1 CYSTOSCOPE