BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 6347844 · Received February 21, 2017

    Report

    Report Number
    2242352-2017-00172
    Event Type
    Malfunction
    Date Received
    February 21, 2017
    Date of Event
    January 24, 2017
    Report Date
    February 21, 2017
    Manufacturer
    MAQUET CV
    Product Code
    DXC
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. 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)(6). (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. SIGNS OF BLOOD AND CLINICAL USE WERE OBSERVED. THE HEATER WIRE WAS FLEXED AWAY FROM THE HOT JAW BUT REMAINED ATTACHED AT THE BASE AND THE TIP OF THE JAW. SLIGHT AMOUNT OF CHARRED TISSUE WAS OBSERVED ON THE HOT JAW. NO OTHER VISUAL DEFECTS WERE OBSERVED. THE DEVICE WAS EVALUATED FOR ELECTRICAL/CAUTERY FUNCTION. A PRE-CAUTERY TEST WAS PERFORMED PER THE INSTRUCTION FOR USE (IFU) WITH A REFERENCE CABLE AND REFERENCE POWER SUPPLY VH-3010 AT LEVEL 2.5. THE DEVICE PASSED THE PRE-CAUTERY TEST; IT PRODUCED VISIBLE STEAM DURING SEVERAL ACTIVATIONS OVER A PERIOD OF 10 MINUTES AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. THE PRE-CAUTERY TEST WAS REPEATED 10 TIMES WHILE THE CABLE CONNECTIONS WERE MANIPULATED WITH NO OBSERVED FAILURE. AN ACTIVATION AND TRANSECTION CAPABILITY TEST WAS PERFORMED OVER TEN (10) REPETITIONS USING MAX LIFE TEST METHOD . THE DEVICE ACTIVATED AND TRANSECTED TISSUE TEN (TEN) TIMES WITH NO CAUTERY FAILURE OBSERVED. THE HANDLE WAS OPENED TO EVALUATE THE INTERNAL COMPONENTS. NO VISIBLE DEFECTS WERE OBSERVED TO THE TOGGLE. THE SWITCH WAS EXAMINED UNDER MICROSCOPY. NO RESIDUE OR CONTAMINATION WAS SEEN ON THE SWITCH. WE WERE UNABLE TO OBSERVE ANY ELECTRICAL ISSUES OR FAILURE TO ENERGIZE FOR THE COMPLAINT UNIT DURING OUR TESTING. BASED ON THE RETURN CONDITION OF THE DEVICE AND THE EVALUATION RESULTS, THE REPORTED COMPLAINT IS NOT CONFIRMED FOR "FAILURE TO CUT" BUT IS CONFIRMED FOR THE FAILURE MODE "BENT WIRE".

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO CAUTERY IN THE EVH SET MALFUNCTIONED. THE METAL PART RAISED THE BOTTOM LEDGE AND DID NOT WORK ANYMORE. 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 HEMOPRO CAUTERY IN THE EVH SET MALFUNCTIONED. THE METAL PART RAISED THE BOTTOM LEDGE AND DID NOT WORK ANYMORE. 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
    129945 VASO VIEW HEMOPRO CLAMP, VASCULAR DXC MAQUET CV 25129386

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR