BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9350912 · Received November 20, 2019

    Report

    Report Number
    3005075853-2019-23624
    Event Type
    Injury
    Date Received
    November 20, 2019
    Report Date
    October 24, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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: LAPAROSCOPIC BILIARY BYPASS ¿ A SINGLE CENTRE EXPERIENCE. AUTHORS: CN TANG, WT SIU, JPY HA, CK TAI, KK TSUI, MKW LI. CITATION: HEPATO-GASTROENTEROLOGY. 2007; 54: 503-507. THE AIM OF THE STUDY WAS TO REVIEW THE RESULTS OF LAPAROSCOPIC BILIARY BYPASS FOR BOTH BENIGN AND MALIGNANT PATHOLOGIES IN A MINIMAL ACCESS SURGERY TRAINING CENTER. THIS IS A RETROSPECTIVE REVIEW OF A PROSPECTIVELY MAINTAINED DATABASE OF 26 LAPAROSCOPIC BILIARY BYPASS (AGE RANGE: 40 TO 92 YEARS OLD; 18 FEMALES 8 MALE PATIENTS) DURING THE PERIOD 1995 TO 2004. DURING THE LAPAROSCOPIC CHOLECYSTOJEJUNOSTOMY (LCCJ) SURGICAL PROCEDURE, THE ROUX LIMB WAS FIRSTLY SUTURED TO THE GALLBLADDER, AND THEN SIDE-TO-SIDE ENTEROTOMY AND CHOLECYSTOTOMY WERE MADE USING ULTRACISION ULTRASONIC DISSECTOR (ETHICON). THE ANASTOMOSIS WAS THEN CONSTRUCTED BY PASSING AND FIRING THE SAME STAPLER. THE FINAL DEFECT WAS CLOSED BY RUNNING CONTINUOUS MONOCRYL 3-0 SUTURE (ETHICON). DURING THE LAPAROSCOPIC CHOLEDOCHOJEJUNOSTOMY PROCEDURE (LCJ), IT WAS MORE OR LESS THE SAME AS THE LCCJ PROCEDURE. THE FINAL ENTEROTOMY DEFECT WAS CLOSED WITH MONOCRYL 3-0 SUTURES (ETHICON). DURING THE LAPAROSCOPIC CHOLEDODUODENOSTOMY PROCEDURE (LCD), THE APPROXIMATION OF THE COMMON BILE DUCT AND DUODENUM USUALLY STARTED AT THE MIDPOINT OF THE POSTERIOR ROW AND THIS WAS FINISHED WITH INTERRUPTED MONOCRYL 3-0 (ETHICON, EDINBURGH, SCOTLAND, UK) UNTIL THE TWO CORNERS WERE REACHED. IN ALL THREE PROCEDURES, REPORTED COMPLICATIONS INCLUDED LOST BROKEN TIP OF THE ULTRASONIC DISSECTOR (N-2) WHICH REQUIRED OPEN CONVERSIONS, SIGNIFICANT BLEEDING DURING THE CHOLEDOCHOTOMY PROCEDURE (N-2), SELF-LIMITING BILE LEAKS (N-3) AND WERE RESOLVED ON CONSERVATIVE MEASURES WITHOUT REOPERATION, WOUND INFECTION (N-1), AND INTRAABDOMINAL COLLECTION (N-1) PROLONGED ANTIBIOTIC TREATMENT. IN CONCLUSION, THE SERIES HAVE DEMONSTRATED THAT LAPAROSCOPIC BILIARY BYPASS CAN BE PERFORMED WITH GOOD LONG-TERM FUNCTIONAL OUTCOME AND ASSOCIATED WITH MINIMAL POSTOPERATIVE COMPLICATION. THE AUTHORS WOULD RECOMMEND THAT IAPAROSCOPIC BILIARY BYPASS SHOULD ALWAYS BE CONSIDERED IN CAREFULLY SELECTED PATIENTS PARTICULARLY FOR THOSE WITH RECURRENT PRIMARY COMMON BILE DUCT STONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140157 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention