BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB

    MDR report key: 5752341 · Received June 27, 2016

    Report

    Report Number
    2242352-2016-00598
    Event Type
    Malfunction
    Date Received
    June 27, 2016
    Report Date
    May 31, 2016
    Manufacturer
    MAQUET CV
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED SECTIONS: DEVICE AVAILABLE FOR EVALUATION?, DATE RECEIVED BY MFR., TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, DEVICE EVALUATED BY MFR?, EVALUATION CODES, ADDITIONAL MFR NARRATIVE. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. THERE WERE SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD. A MECHANICAL EVALUATION OF THE HEMOPRO BISECTOR BLADE SLIDER WAS CONDUCTED. THE SWITCH WAS ABLE TO ADVANCE AND RETRACT THE BLADE WITH NO OBSERVED DIFFICULTY. THERE WAS NO RESISTANCE FELT THAT COULD BE CONSIDERED EXCESSIVE. A SECOND INVESTIGATOR TESTED THE DEVICE AND FOUND NO NONCONFORMANCE. BASED ON THE RETURNED CONDITION OF THE DEVICE AND THE RESULTS OF THE INVESTIGATION, THE REPORTED COMPLAIN WAS NOT CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB SLIDING BUTTON WAS STICKING. 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, VASOVIEW 7 XB SLIDING BUTTON WAS STICKING. 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
    407706 VASOVIEW 7 XB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CV 25122606

    Patients

    Seq Age Sex Outcome Treatment
    1