BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9434102 · Received December 6, 2019

    Report

    Report Number
    3005075853-2019-24074
    Event Type
    Injury
    Date Received
    December 6, 2019
    Date of Event
    January 1, 2004
    Report Date
    November 7, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2004. BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: THE USE OF BOVINE PERICARDIAL STRIPS ON LINEAR STAPLER TO REDUCE EXTRALUMINAL BLEEDING DURING LAPAROSCOPIC GASTRIC BYPASS: PROSPECTIVE RANDOMIZED CLINICAL TRIAL. AUTHOR/S: LUIGI ANGRISANI, MD, CHM; MICHELE LORENZO, MD, PHD; VINCENZO BORRELLI, MD; MONICA CIANNELLA, MD; UBERTO ANDREA BASSI, MD; PAOLO SCARANO, MD. CITATION: OBESITY SURGERY. 14: 1198-1202. A PROSPECTIVE COMPARISON WAS CONDUCTED OF EXTRALUMINAL BLEEDING FOLLOWING GASTRIC TRANSECTION WITH OR WITHOUT STAPLE-LINE REINFORCEMENT BY DEHYDRATED BOVINE PERICARDIUM DURING LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (LRYGBP). FROM JANUARY 2001 TO SEPTEMBER 2003, A TOTAL OF 98 CONSECUTIVE MORBIDLY OBESE PATIENTS UNDERWENT LRYGBP. PATIENTS WERE RANDOMLY ALLOCATED TO 2 GROUPS ACCORDING TO THE USE (GROUP A, 50 PATIENTS; AGE RANGE: 19 TO 58 YEARS OLD; 12 MALE AND 38 FEMALE PATIENTS; BMI: 37 TO 59) OR NOT (GROUP B, 48 PATIENTS; AGE RANGE: 20 TO 60 YEARS OLD; 10 MALE AND 38 FEMALE PATIENTS; BMI: 38 TO 58) OF DEHYDRATED BOVINE PERICARDIUM. IN BOTH GROUPS, DISSECTION WAS STARTED AT THE EQUATOR OF THE BALLOON IN THE PERI-GASTRIC SPACE BETWEEN THE NEUROVASCULAR BUNDLE OF LATARJET AND LESSER CURVATURE OF THE STOMACH USING THE HARMONIC SCALPEL (ETHICON). THE ANASTOMOSIS WAS COMPLETED BY PDS 2-0 CONTINUOUS SUTURES (ETHICON). IN GROUP A, REPORTED COMPLICATIONS INCLUDED SHORT GASTRIC VESSELS BLEEDING (N-1) WHICH REQUIRED CONVERSION TO LAPAROTOMY. IN GROUP B, REPORTED COMPLICATIONS INCLUDED LEAK (N-7) WHICH REQUIRED INTERRUPTED STITCHES INSERTED TO CONTROL THE LEAK IN 1 CASE AND ONE CASE OF POSTERIOR LEAK AND UNSATISFACTORY EXPOSURE WHICH REQUIRED CONVERSION TO LAPAROTOMY. IN CONCLUSION, PERI-STRIPS DRY CAN BE SAFELY APPLIED TO LINEAR STAPLERS FOR LRYGBP. THE BENEFIT OF PSD REINFORCEMENT OF THE GASTRIC STAPLE-LINES TO PREVENT BLEEDING WAS DEMONSTRATED BY A SIGNIFICANT REDUCTION IN THE NUMBER OF ENDO-CLIPS USED. AS A CONSEQUENCE OF LESS STAPLE-LINE BLEEDING, A DRY OPERATING FIELD WAS OBTAINED. THE EXTRA TIME REQUIRED TO IDENTIFY A BLEEDING SOURCE AND CONTROL IT WAS SAVED, AND THE TOTAL OPERATING-TIME WAS SIGNIFICANTLY REDUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228351 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention