BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9652711 · Received January 31, 2020

    Report

    Report Number
    3005075853-2020-00642
    Event Type
    Injury
    Date Received
    January 31, 2020
    Report Date
    January 3, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2012. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/ SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    TITLE: COMPLICATIONS AND OUTCOME AFTER LAPAROSCOPIC BARIATRIC SURGERY: LAGB VERSUS LRYGB, AUTHOR: NIKOLAUS P. ZUEGEL & REINHOLD A. LANG & THOMAS P. HÜTTL & MARC GLEIS & MARGUERITE KETFI-JUNGEN & ISABELLE RASQUIN & MARTIN KOX, CITATION: LANGENBECKS ARCH SURG (2012) 397:1235¿1241, DOI 10.1007/S00423-012-0945-5. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO COMPARE EARLY AND LATE POSTOPERATIVE COMPLICATIONS AS WELL AS SHORT-TERM (6 MONTHS TO 2 YEARS), MIDDLE-TERM (2 TO 5 YEARS), AND LONG-TERM (>5 YEARS) RESULTS OF LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING (LAGB) VERSUS LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (LRYGB) FOR THE PERCENTAGE OF EXCESS BODY WEIGHT LOSS (%EBWL) AND THE BARIATRIC ANALYSIS AND REPORTING OUTCOME SYSTEM (BAROS) EVALUATION. BETWEEN JUNE 1994 AND DECEMBER 2007, A TOTAL OF 620 BARIATRIC PROCEDURES WERE PERFORMED FOR THE TREATMENT OF SEVERE OBESITY (N=204 LAGB [157 FEMALES, 47 MALES, MEAN AGE 36 YEARS] AND N=416 LRYGB [324 FEMALES, 92 MALES, MEAN AGE 37 YEARS]). UNDER VISUALIZATION OF THE GASTROESOPHAGEAL JUNCTION, THE ANGLE OF HIS WAS DISSECTED FROM ITS DIAPHRAGMATIC ATTACHMENTS. APPROXIMATELY 5-7 CM BELOW THE GASTROESOPHAGEAL JUNCTION, A RETROGASTRIC TUNNEL WAS FORMED AT THE MINOR CURVE USING THE HARMONIC SCALPEL ULTRACISION (ETHICON) OR THE LIGASURE. COMPLAINTS (=30 DAYS) FOR LAGB GROUP INCLUDED INTRA-OPERATIVE PERFORATION OF THE POSTERIOR WALL OF THE STOMACH (N=?) WHICH OCCURRED DURING THE PREPARATION OF THE RETRO-GASTRIC WINDOW AND WAS CLOSED PRIMARILY WITHOUT SIDE EFFECTS, BLEEDING OF THE SHORT GASTRIC VESSELS (N=?) AND WAS CONTROLLED DURING THE PRIMARY LAPAROSCOPIC PROCEDURE. COMPLAINTS (=30 DAYS) FOR LRYGB GROUP WERE ABDOMINAL BLEEDING FROM GASTRIC VESSELS (N=?) WHICH WAS SOLVED DURING THE PRIMARY LAPAROSCOPIC PROCEDURE USING THE ULTRACISION DEVICE. THIS STUDY DEMONSTRATES THAT SURGICAL TREATMENT OF SEVERE OBESITY ACHIEVES EFFECTIVE AND LONG-LASTING WEIGHT LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117578 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other