BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR

    MDR report key: 8540065 · Received April 23, 2019

    Report

    Report Number
    3005075853-2019-18315
    Event Type
    Injury
    Date Received
    April 23, 2019
    Report Date
    March 27, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. DATE OF EVENT IS UNKNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF A JOURNAL ARTICLE: TITLE: RANDOMIZED CLINICAL TRIAL OF TORSIONAL VERSUS LINEAR MODE ULTRASONICALLY ACTIVATED DEVICES FOR LAPAROSCOPIC CHOLECYSTECTOMY. AUTHOR(S): SIOK S. CHING, ABEEZAR I. SARELA, JEREMY D. HAYDEN, MICHAEL J. MCMAHON. CITATION: SURG ENDOSC. 2009; 23: 1506¿1511. DOI: 10.1007/S00464-009-0391-9. CONVENTIONAL ULTRASONICALLY ACTIVATED DEVICES USE LINEAR MODE VIBRATION. TORSIONAL MODE ULTRASONICALLY ACTIVATED DEVICE (TM) THAT OSCILLATE AROUND AN ARC HAVE BEEN RECENTLY INTRODUCED IN THE HOPE THAT THE DESIGN MAY RESULT IN FASTER CUTTING AND BETTER HEMOSTASIS. PATIENTS UNDERGOING ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY WERE RANDOMIZED TO TM (75 PATIENTS; 60 FEMALE AND 15 MALE PATIENTS; AGE RANGE: 23 TO 81 YEARS OLD; BMI: 19.4 TO 46.3) OR LINEAR MODE ULTRASONICALLY ACTIVATED DEVICE (LM; 76 PATIENTS; 59 FEMALE AND 17 MALE PATIENTS; AGE RANGE: 16 TO 81 YEARS OLD; BMI: 17.3 TO 52.1). THE LM GROUP USED A HARMONIC SCALPEL (ETHICON) USING THE SINGLE-USE LCSC5 SHEARS (ETHICON) WITH A 15-MM ACTIVE CURVED BLADE. IN BOTH GROUPS DURING THE PROCEDURE, THE CYSTIC ARTERY WAS SEALED AND DIVIDED WITH THE ULTRASONIC DEVICE AND THE CYSTIC DUCT WAS LIGATED WITH ABSOLOK PDS LOCKING CLIP (ETHICON). IN THE TM GROUP, REPORTED COMPLICATIONS INCLUDED GALLBLADDER PERFORATION (N-22). IN THE LM GROUP, REPORTED COMPLICATIONS INCLUDED GALLBLADDER PERFORATION (N-24), POST-OPERATIVE BLEEDING (N-1), MASSIVE HEMORRHAGE (N-1) WHICH WAS CONTROLLED BY LAPAROSCOPIC SUTURING, HEMOPERITONEUM (N-1) WHICH REQUIRED LAPAROSCOPIC EXPLORATION, AND INEFFECTIVE HEMOSTASIS DURING TISSUE DISSECTION (N-66) WHICH REQUIRED RE-APPLICATION OF THE DEVICE IN 43 PATIENTS, USE OF SURGICEL ABSORBABLE HEMOSTAT (ETHICON) IN 10 PATIENTS, AND USE OF ELECTROSURGERY IN 13 PATIENTS. THE PRESENT STUDY CONCLUDED THAT TORSIONAL MODE ULTRASONICALLY ACTIVATED DEVICE IS SIMILAR IN EFFECTIVENESS AND SAFETY TO THE LINEAR MODE HARMONIC SCALPEL AS CONVINCING EVIDENCE FOR SUPERIORITY HAS NOT BEEN DEMONSTRATED. THERE IS, HOWEVER, A COST BENEFIT FOR USING THE TM COMPARED WITH THE HARMONIC SCALPEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335150 HARMONIC SCALPEL CURVED SHEAR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention