BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB

    MDR report key: 6459109 · Received April 4, 2017

    Report

    Report Number
    2242352-2017-00342
    Event Type
    Malfunction
    Date Received
    April 4, 2017
    Report Date
    April 5, 2017
    Manufacturer
    MAQUET CV
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE FACILITY FOR EVALUATION. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD AND CHARRED TISSUE WERE OBSERVED. A VISUAL INSPECTION WAS PERFORMED. THE VV7 BISECTOR WAS RETURNED INSIDE THE CANNULA. NO VISUAL DEFECTS WERE OBSERVED. THE BISECTOR WAS INSERTED AND RETRACTED THROUGH THE ADAPTOR PORT OF THE HARVESTING CANNULA. THE VV7 BISECTOR SLID NORMALLY. THERE WAS NO RESISTANCE FELT WHICH COULD BE CALLED INAPPROPRIATE. A SECOND INVESTIGATOR WAS ALSO ABLE TO INSERT AND RETRACT THE VV7 BISECTOR INTO THE CANNULA WITH NO DIFFICULTY. BASED ON THE INVESTIGATION AND DEVICE AS RETURNED. THE REPORTED FAILURE MODE, "MECHANICAL ISSUE" WAS NOT CONFIRMED. THERE IS NO EXISTING CAPA/FIR FOR THE REPORTED FAILURE MODE; NO ESCALATION IS REQUIRED AT THIS TIME SINCE THE REPORTED FAILURE MODE WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVOEW 7 XB DISSECTION DEVICE DID NOT SMOOTHLY INSERT THROUGH HARVESTING CANNULA. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVOEW 7 XB DISSECTION DEVICE DID NOT SMOOTHLY INSERT THROUGH HARVESTING CANNULA. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240625 VASOVIEW 7 XB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CV

    Patients

    Seq Age Sex Outcome Treatment
    1