BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR URETERAL ACCESS SHEATH AND DILATORS

    MDR report key: 5108595 · Received September 28, 2015

    Report

    Report Number
    1820334-2015-00624
    Event Type
    Injury
    Date Received
    September 28, 2015
    Report Date
    August 31, 2015
    Manufacturer
    COOK INC
    Product Code
    KOE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFG DATE: UNKNOWN AS NO LOT # WAS PROVIDED. THE EVENT IS CURRENTLY UNDER INVESTIGATION. MFG DATE: UNKNOWN AS NO LOT # WAS PROVIDED. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: NO PRODUCT WAS RETURNED; HOWEVER, A REVIEW OF COMPLAINT HISTORY, MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION PER SPECIFICATION, QUALITY CONTROL ASSURES THE PRESENCE OF THE DILATOR TAPER AND ASSURE SMOOTH TRANSITION BETWEEN THE SHEATH AND DILATOR. THERE IS NO EVIDENCE TO INDICATE THE PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. WITHOUT THE BENEFIT OF A RETURNED COMPLAINT DEVICE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED, AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. BASED ON THE HEALTH RISK ASSESSMENT, NO RISK MITIGATION ACTIVITIES ARE NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    PER THE JOURNAL ARTICLE, BACH, ET AL: THE NEW DIGITAL FLEXIBLE URETEROSCOPES: "SIZE DOES MATTER" - INCREASED URETERIC ACCESS SHEATH USE!: THERE WERE TWO SHEATH-RELATED SMALL DISTAL URETERIC PERFORATIONS IN THE D-FURS GROUP. THEY WERE TREATED WITH POSTOPERATIVE JJ STENTS AND DID NOT DEVELOP STRICTURES ON FOLLOW UP. THEY WERE TREATED WITH POSTOPERATIVE JJ STENTS AND DID NOT DEVELOP STRICTURES ON FOLLOW UP.

    Description of Event or Problem · 1

    PER THE JOURNAL ARTICLE, BACH, ET AL: THE NEW DIGITAL FLEXIBLE URETEROSCOPES: "SIZE DOES MATTER" - INCREASED URETERIC ACCESS SHEATH USE!: THERE WERE TWO SHEATH-RELATED SMALL DISTAL URETERIC PERFORATIONS IN THE D-FURS GROUP. THEY WERE TREATED WITH POSTOPERATIVE JJ STENTS AND DID NOT DEVELOP STRICTURES ON FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639823 FLEXOR URETERAL ACCESS SHEATH AND DILATORS KOE DILATOR, URETHRAL KOE COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1