BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 9354430 · Received November 21, 2019

    Report

    Report Number
    2210968-2019-90169
    Event Type
    Injury
    Date Received
    November 21, 2019
    Report Date
    November 4, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: INT J COLORECTAL DIS (2007); 22:801¿806. DOI: 10.1007/S00384-006-0242-2. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: SIMPLE HARMONIC SCALPEL HEMORRHOIDECTOMY UTILIZING LOCAL ANESTHESIA COMBINED WITH INTRAVENOUS SEDATION: A SAFE AND RAPID ALTERNATIVE TO CONVENTIONAL HEMORRHOIDECTOMY. AUTHORS: LIAM A. HAVERAN, PAUL R. STURROCK, MARK Y. SUN, JANET MCDADE & SUDERSHAN SINGLA, CRAIG A. PATERSON, TIMOTHY C. COUNIHAN CITATION: INT J COLORECTAL DIS (2007); 22:801¿806. DOI: 10.1007/S00384-006-0242-2. THE AIM OF THE PRESENT STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF SIMPLE HARMONIC SCALPEL® HEMORRHOIDECTOMY (HSH) PERFORMED WITH COMBINATION DEEP INTRAVENOUS SEDATION AND LOCAL ANESTHESIA IN AN AMBULATORY SURGICAL CENTER. A RETROSPECTIVE REVIEW INVOLVES 180 PATIENTS (94 MALE AND 86 FEMALE; MEAN AGE: 49±14 YEARS; AGE RANGE 17¿88 YEARS) WHO UNDERWENT HSH IN AN AMBULATORY SURGICAL CENTER FROM OCTOBER 2001 TO JULY 2005. THE INTERNAL AND EXTERNAL COMPONENTS OF EACH HEMORRHOIDAL COMPLEX IS GRASPED AND ELEVATED BY A TOOTH FORCEPS AND THE HEMORRHOID BUNDLE IS CAREFULLY DISSECTED OFF THE INTERNAL ANAL SPHINCTER USING THE HARMONIC SCALPEL® SHEARS (ETHICON). CONTROL OF THE PEDICLE WAS ACHIEVED BY COAGULATION USING THE SAME DEVICE. HEMOSTASIS IS OBTAINED USING THE HARMONIC SCALPEL® SHEARS (ETHICON) OR ELECTROCAUTERY. A SMALL PIECE OF SURGICEL (ETHICON) WAS PLACED AT THE ANAL VERGE. REPORTED COMPLICATIONS INCLUDED PAIN (N-1) IN WHICH THE PATIENT WAS ADMITTED, FEVER (N-2) IN WHICH THE PATIENTS WERE ADMITTED OVERNIGHT AND DISCHARGED THE FOLLOWING DAY ON ORAL ANTIBIOTICS, AND FISSURE (N-2). IN CONCLUSION, HARMONIC SCALPEL® HEMORRHOIDECTOMY PERFORMED WITH PROPOFOL/KETAMINE INTRAVENOUS SEDATION AND LOCAL ANESTHESIA IN AN AMBULATORY SETTING RESULTS IN FAST OPERATIVE TIMES, NEGLIGIBLE MORBIDITY, RAPID DISCHARGE FROM THE HOSPITAL AND THE POTENTIAL FOR SUBSTANTIAL COST SAVINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147900 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention