BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9264066 · Received October 31, 2019

    Report

    Report Number
    3005075853-2019-23135
    Event Type
    Injury
    Date Received
    October 31, 2019
    Report Date
    October 4, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    TITLE: DOUBLE-BLIND, RANDOMIZED TRIAL COMPARING HARMONIC SCALPEL¿ HEMORRHOIDECTOMY, BIPOLAR SCISSORS HEMORRHOIDECTOMY, AND SCISSORS EXCISION LIGATION TECHNIQUE. AUTHOR/S: C. C. CHUNG, F.R.C.S.E., J. P. Y. HA, F.R.C.S.E., Y. P. TAI, F.R.S.C.E., W. W. C. TSANG, F.R.C.S.E, M. K. W. LI, F.R.C.S.(ENG.), F.R.C.S.E. CITATION: DIS COLON RECTUM (2002); 45:789¿794. THE AIM OF THIS STUDY WAS TO COMPARE THE OUTCOME OF PATIENTS RECEIVING HEMORRHOIDECTOMY USING HARMONIC SCALPEL, BIPOLAR SCISSORS, AND THE CONVENTIONAL SCISSORS EXCISION¿LIGATION TECHNIQUE. THIS DOUBLE-BLIND RANDOMIZED TRIAL FROM APRIL 1999 TO JANUARY 2001 INCLUDES 86 PATIENTS WITH IRREDUCIBLE PROLAPSING PILES. THE PATIENTS WERE RANDOMLY ALLOCATED TO ONE OF THE FOLLOWING THREE GROUPS: IN MMH GROUP, 27 PATIENTS (13 MALE AND 14 FEMALE; MEAN AGE: 44.7±14.5 YEARS) UNDERWENT MILLIGAN-MORGAN HEMORRHOIDECTOMY (MMH); IN BSH GROUP, 30 PATIENTS (16 MALE AND 14 FEMALE; MEAN AGE: 50.7±12.2 YEARS) UNDERWENT BIPOLAR SCISSORS HEMORRHOIDECTOMY USING POWERSTAR BIPOLAR SCISSORS (ETHICON); AND IN HSH GROUP, 29 PATIENTS (13 MALE AND 16 FEMALE; MEAN AGE: 49±14.9 YEARS) UNDERWENT HARMONIC SCALPEL HEMORRHOIDECTOMY USING HARMONIC SCALPEL (ULTRACISION 10-MM COAGULATING SHEARS; ETHICON). IN THE BSH GROUP, THE SKIN INCISION WAS MADE BY MEANS OF THE BIPOLAR SCISSORS WITHOUT CAUTERY, TO AVOID BURNING OF THE SKIN BRIDGES. THE HEMORRHOIDAL BUNDLE WAS CAREFULLY DISSECTED OFF THE INTERNAL SPHINCTER, UP TO THE PEDICLE AT THE ANORECTAL RING. THE HEMORRHOID WAS THEN EXCISED. BLEEDING, IF ANY, WAS CONTROLLED BY THE BIPOLAR SCISSORS CAUTERY. THE PEDICLE OF EACH HEMORRHOID WAS GRASPED AND COAGULATED BETWEEN THE SCISSORS RATHER THAN BEING TRANSFIXED. IN HSH GROUP, THE OPERATION RESEMBLED BSH, EXCEPT THAT THE DISSECTION AND HEMOSTASIS WERE PURELY PERFORMED WITH THE HARMONIC SCALPEL. AGAIN, THE PEDICLE WAS CONTROLLED BY COAGULATION USING THE HARMONIC SCALPEL. REPORTED COMPLICATION IN THE BSH GROUP INCLUDED PAIN/WORSENED PAIN (N-?), URINARY RETENTION (N-1), FEVER (N-1), AND ANAL STENOSIS (N-1), AND IN THE HSH GROUP INCLUDED PAIN/WORSENED PAIN (N-?), AND FLATUS INCONTINENCE (N-1). IN CONCLUSION, THE STUDY SHOWS THAT HARMONIC SCALPEL HEMORRHOIDECTOMY IS AS GOOD AS BIPOLAR SCISSORS HEMORRHOIDECTOMY IN TERMS OF REDUCED BLOOD LOSS BUT IS SUPERIOR BECAUSE IT IS ASSOCIATED WITH LESS POSTOPERATIVE PAIN AND HENCE, BETTER PATIENT SATISFACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053647 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention