BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB

    MDR report key: 5621535 · Received April 29, 2016

    Report

    Report Number
    2242352-2016-00416
    Event Type
    Malfunction
    Date Received
    April 29, 2016
    Date of Event
    April 4, 2016
    Report Date
    April 5, 2016
    Manufacturer
    MAQUET CV
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. EVIDENCE OF BLOOD AND SIGNS OF CLINICAL USE WERE OBSERVED ON THE CANNULA. THERE WERE NO BLEMISHES/ FLASH, NO DAMAGE TO C-RING, NO DAMAGE TO BLUNT TIP, NO DAMAGE TO BLADE, SCISSORS, SHAFT TIP OR SHAFT HUB ASSEMBLY. A MECHANICAL EVALUATION WAS CONDUCTED. THE C-RING SLIDER WAS ABLE TO ADVANCE AND RETRACT THE C-RING WITH NO RESISTANCE. THE PRODUCT PERFORMED AS INTENDED. THE DEVICE WAS EVALUATED BY A SECOND INVESTIGATOR. NO VISIBLE FLAWS WERE NOTED DURING VISUAL INSPECTION. THE C-RING EXTENDED & RETRACTED AS EXPECTED WITH NO RESISTANCE. THE SECOND INVESTIGATOR AGREED AND CONFIRMED THAT THE PRODUCT PERFORMED AS INTENDED. THE EVENT OCCURRED DURING THE USE OF THE DEVICE AND THE PROCEDURAL OPERATION IS UNAVAILABLE FOR OUR REVIEW. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THE RECORDS SHOW THE DEVICE LOT CONFORMED TO ALL APPLICABLE SPECIFICATIONS. BASED ON THE RESULTS OF THE EVALUATION, THE REPORTED COMPLAINT FOR "WOULD NOT ADVANCE/MECHANICAL ISSUE" COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB JAWS WOULD NOT ADVANCE ONCE THE BISECTOR WAS INSIDE THE LEG. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT IS RETURNING. THE PA SAID THAT THE JAWS WOULD NOT ADVANCE ONCE THE BISECTOR WAS INSIDE THE LEG.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB JAWS WOULD NOT ADVANCE ONCE THE BISECTOR WAS INSIDE THE LEG. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT IS RETURNING. THE PA SAID THAT THE JAWS WOULD NOT ADVANCE ONCE THE BISECTOR WAS INSIDE THE LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276575 VASOVIEW 7 XB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CV 25121563

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR