BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALLE PYELOPLASTY STENT SET

    MDR report key: 6748294 · Received July 27, 2017

    Report

    Report Number
    1820334-2017-01863
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Date of Event
    June 16, 2017
    Report Date
    February 21, 2018
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002327733
    PMA / PMN Number
    K810368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE CONNECTING TUBE AND 050010 WERE RECEIVED. THE STENT AND REMAINING SET COMPONENTS WERE NOT RETURNED. CONNECTING TUBE CTU-10-30-NSTC AND 050010 ADAPTER ARE PART OF THE SET FOR SIPSF-040018-5.9. THE END OF THE CONNECTING TUBE HAD A 050010 ADAPTER ATTACHED TO THE MALE LUER LOCK ADAPTER (MLLA). THE ADAPTER DID NOT HAVE A BLACK O-RINGS INSIDE THE CAP. DURING INVESTIGATION, IT WAS FOUND OUT THAT THE MISSING O RING IN THE ADAPTER CAUSED THE CUSTOMER'S DIFFICULTY. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. BASED ON THE INVESTIGATION EVALUATION, THERE IS AN INDICATION THAT A PROCESS-RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT, HOWEVER A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. RELEVANT PERSONNEL HAVE BEEN NOTIFIED AND MONITORING OF THIS COMPLAINT ISSUE HAS BEEN INSTITUTED. WE WILL NOTIFY THE APPROPRIATE PERSONNEL AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    REPORT RECEIVED VIA FDA - MEDSUN REPORT (B)(4) STATING "THE WHITE CONNECTOR ON THE SALLE STENT WAS NOT WORKING PROPERLY." ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATES THAT THE WHITE CONNECTOR WAS REPLACED. THE CONNECTOR WAS IN USE FOR LESS THAN ONE DAY. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION; HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526880 SALLE PYELOPLASTY STENT SET FAD STENT, URETERAL FAD COOK INC N/A 00827002327733

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR