BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 8516766 · Received April 15, 2019

    Report

    Report Number
    2242352-2019-00441
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    March 21, 2019
    Report Date
    April 12, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED SECTION: CHANGED PMA/510(K)# FROM "K130382" TO "K052274". INTERNAL COMPLAINT # (B)(4). AUTONUMBER # (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND SLIGHT EVIDENCE OF BLOOD WAS OBSERVED. SLIGHT BLOOD WAS OBSERVED ON THE HARVESTING HANDLE. BLOOD AND CHARRED TISSUE WAS OBSERVED ON THE HEATER WIRE. NO VISUAL DEFECTS WERE OBSERVED. AN ELECTRICAL EVALUATION WAS CONDUCTED. A PRE-CAUTERY TEST AS WAS PERFORMED PER THE INSTRUCTION FOR USE 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 5 TIMES WHILE THE CABLE CONNECTIONS WERE MANIPULATED WITH NO OBSERVED FAILURE. 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 RESULTS OF THE EVALUATION, THE REPORTED COMPLAINT FOR ¿FAILURE TO DELIVER ENERGY¿ WAS UNABLE TO BE CONFIRMED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO JAWS WOULD NOT ACTIVATE. 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 AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO JAWS WOULD NOT ACTIVATE. 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
    309851 VASO VIEW HEMOPRO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC 25144599

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR