BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9293621 · Received November 7, 2019

    Report

    Report Number
    3005075853-2019-23338
    Event Type
    Injury
    Date Received
    November 7, 2019
    Report Date
    October 10, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    TITLE: ENDOSCOPIC RADIAL ARTERY HARVEST¿OUTCOMES AND LESSONS LEARNED AFTER 1000 HARVESTS. AUTHOR/S: S SWINAMER, S FOX, D NAGPAL, M CHU, M QUANTZ, R GUO, R NOVICK, B KIAII, J SY, J GELINAS. CITATION: CANADIAN JOURNAL OF CARDIOLOGY (2017); VOLUME 33. THE AUTHORS PRESENTED THEIR EXPERIENCE AND OUTCOMES WITH THE TECHNIQUE AFTER MORE THAN 1000 HARVESTS. FROM JULY 2004 TO PRESENT, A TOTAL OF 1003 PATIENTS UNDERWENT ENDOSCOPIC RADIAL ARTERY HARVEST (ERAH). A REUSABLE ESVH SYSTEM WITH THE ADDITION OF A HARMONIC ULTRASONIC SCALPEL/SHEARS (ETHICON) TO FACILITATE THE REMOVAL OF THE RADIAL ARTERY (RA) FOR USE IN THE CABG PATIENTS. REPORTED COMPLICATIONS INCLUDED NEUROLOGICAL IMPAIRMENTS (N-?), TRANSIENT NUMBNESS OVER THE THENAR EMINENCE, INDEX FINGER AND LATERAL FOREARM (N-?), AND NEURALGIAS (N-5), IN CONCLUSION, ERAH CAN BE EFFECTIVELY AND SAFELY ADOPTED AS A HARVEST TECHNIQUE FOR THE RA FOR CABG. THE RESULTS DEMONSTRATE ERAH PROVIDES ADEQUATE LENGTH CONDUITS IN A TIMELY MANNER THROUGH MUCH SMALLER INCISIONS, RESULTING IN LOW RATES OF INFECTION, NEUROLOGICAL IMPAIRMENT, EXCELLENT LONG-TERM PATENCY AND NO EVIDENCE OF HISTOLOGICAL DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088451 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other