BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, INFRAVISION UNIVERSAL URETERAL KIT (BOX OF 5)

    MDR report key: 7074927 · Received December 1, 2017

    Report

    Report Number
    0002936485-2017-01171
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    November 7, 2017
    Report Date
    March 15, 2018
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    FCS
    PMA / PMN Number
    K061548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE ALLEGED FAILURE: IT DIDN¿T WORK WHEN PLUGGED IN THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSE COULD BE A BENT LIGHT FIBER. MFG DATE: MANUFACTURE DATE IS NOT KNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FIBERS WERE NOT LIGHTING UP WHEN INSERTED INTO THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FIBERS WERE NOT LIGHTING UP WHEN INSERTED INTO THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853764 PKG, INFRAVISION UNIVERSAL URETERAL KIT (BOX OF 5) LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL FCS STRYKER ENDOSCOPY-SAN JOSE 1596543

    Patients

    Seq Age Sex Outcome Treatment
    1