BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVH

    MDR report key: 8944436 · Received August 29, 2019

    Report

    Report Number
    2242352-2019-00993
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Report Date
    August 29, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED ON (B)(6) 2019. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. A MECHANICAL EVALUATION WAS CONDUCTED. A REFERENCE ENDOSCOPE WAS INSERTED INTO THE CANNULA UNTIL THE NOTICEABLE CLICK WAS OBSERVED, WITH NO DIFFICULTIES OBSERVED. THE TEST WAS REPEATED 3 (THREE) TIMES WITH THE SAME OBSERVATIONS OBSERVED. BASED ON THE RETURNED CONDITION OF THE DEVICE, THE REPORTED FAILURE "FITTING PROBLEM" WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB BISECTOR SCOPE WOULD NOT INSERT INTO CANNULA. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WERE NO NCMR¿S FOR THE REPORTED LOT NUMBER. THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB BISECTOR SCOPE WOULD NOT INSERT INTO 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
    737922 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEW 7 XB BISECTOR (US) 25145985

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR