BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVH

    MDR report key: 8962235 · Received September 4, 2019

    Report

    Report Number
    2242352-2019-01007
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    August 9, 2019
    Report Date
    September 4, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT NUMBER: (B)(4). SPECIFIC ACTIONS FOR THE ANALYZED FAILURE MODE ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET'S FAILURE INVESTIGATION REPORT (FIR) SYSTEM. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED ON 11/08/2019 A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND SLIGHT EVIDENCE OF BLOOD WAS OBSERVED. BLOOD WAS OBSERVED ON THE HARVESTING HANDLE. BLOOD AND TISSUE WAS OBSERVED ON THE HEATER WIRE. THE HEATER WIRE WAS OBSERVED TO BE SLIGHTLY FLEXED AWAY FROM THE HOT JAW AT THE BASE OF THE HOT JAW, AND REMAINING ATTACHED AT BOTH THE TIP AND BASE OF THE HOT JAW. NO OTHER VISUAL DEFECTS WERE OBSERVED. THE JAWS WERE GENTLY CLEANED OF DEBRIS AND CHAR WITH A SALINE AND GAUZE PAD AS INDICATED IN THE INSTRUCTIONS FOR USE. A PRE-CAUTERY TEST WAS PERFORMED PER THE INSTRUCTION FOR USE (IFU) WITH A REFERENCE CABLE, ADAPTER AND REFERENCE POWER SUPPLY VH-3010 AT LEVEL 3.0. THE DEVICE PASSED THE PRE-CAUTERY TEST; IT PRODUCED VISIBLE STEAM AND HEAT DURING TEN (10) 3-SECOND ACTIVATIONS AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. NO SMOKE AND/OR STEAM WHICH COULD BE CONSIDERED EXCESSIVE WAS OBSERVED DURING THE TESTING. BASED ON THE CONDITION OF THE DEVICE AS RETURNED AND THE RESULTS OF THE INVESTIGATION, THE REPORTED FAILURE ¿ENVIRONMENTAL PARTICULATES¿, IS NOT CONFIRMED. THE ANALYZED FAILURE "MATERIAL TWISTED/BENT; WIRE" IS CONFIRMED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2, THEY CALLED TO NOTIFY OF A PRODUCT MALFUNCTION. SMOKE STARTED EMULATING FROM THE TRIGGER MECHANISM ON THE HEMOPRO WAND DURING LIGATION PHASE OF HARVEST. OR STAFF REPLACED EXTENSION CABLE AND THE PROBLEM CONTINUED. HEMOPRO SYSTEM WAS SET ASIDE AND A SECOND KIT WAS OPENED TO COMPLETE THE VESSEL HARVESTING WITHOUT ANY INCIDENT.

    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 USING VASOVIEW HEMOPRO 2, THEY CALLED TO NOTIFY OF A PRODUCT MALFUNCTION. SMOKE STARTED EMULATING FROM THE TRIGGER MECHANISM ON THE HEMOPRO WAND DURING LIGATION PHASE OF HARVEST. OR STAFF REPLACED EXTENSION CABLE AND THE PROBLEM CONTINUED. HEMOPRO SYSTEM WAS SET ASIDE AND A SECOND KIT WAS OPENED TO COMPLETE THE VESSEL HARVESTING WITHOUT ANY INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756249 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 25147194

    Patients

    Seq Age Sex Outcome Treatment
    1