BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 9711881 · Received February 14, 2020

    Report

    Report Number
    2242352-2020-00146
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    January 21, 2020
    Report Date
    February 12, 2020
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED SECTION: H-3 DEVICE NOT EVAL PROVIDE CODE: FROM "OTHER" TO "DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN." TRACKWISE ID # (B)(4).

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT NUMBER: (B)(4). THE DEVICE WAS RETURNED ON 02/14/2020. AN INVESTIGATION WAS CONDUCTED ON 03/18/2020. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND AMOUNTS OF CHARRED MATERIAL WAS OBSERVED ON THE HEATER WIRE. THE HEATER WIRE WAS OBSERVED TO BE SLIGHTLY FLEXED AWAY AT THE CENTER OF THE HOT JAW, BUT REMAINED ATTACHED AT THE BASE AND TIP OF THE HOT JAW. THE GRAY SILICONE INSULATION ON THE HOT JAW WAS OBSERVED TO BE CRACKED ALONG THE LENGTH OF THE HOT JAW. A PRE-CAUTERY TEST 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 AND AUDIBLE SOUND 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 WITH NO OBSERVED FAILURE. THE TOOL HANDLE WAS OPENED TO EVALUATE THE INTERNAL COMPONENTS. NO VISIBLE DEFECTS WERE OBSERVED TO THE TOGGLE. MICROSCOPIC INSPECTION SHOWED NO RESIDUE OR CONTAMINATION ON THE INNER SWITCH MECHANISM. BASED ON THE RETURNED CONDITION OF THE DEVICE AND THE EVALUATION RESULTS, THE REPORTED FAILURE "SELF-ACTIVATION OR KEYING" WAS NOT CONFIRMED, BUT THE ANALYZED FAILURE MODES ¿MATERIAL TWISTED/BENT¿ AND "THERMAL DECOMPOSITION OF DEVICE " WAS CONFIRMED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO TURNED ON WITHOUT USER INPUT. THE DEVICE GOT "RED HOT" WITH THE JAWS OPEN WHILE INSIDE THE PATIENT .A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO TURNED ON WITHOUT USER INPUT. THE DEVICE GOT "RED HOT" WITH THE JAWS OPEN WHILE INSIDE THE PATIENT .A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    TRACKWISE ID # (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 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.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO TURNED ON WITHOUT USER INPUT. THE DEVICE GOT "RED HOT" WITH THE JAWS OPEN WHILE INSIDE THE PATIENT .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
    173960 VASOVIEW HEMOPRO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000 25147484

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR