BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 9330989 · Received November 15, 2019

    Report

    Report Number
    2210968-2019-89977
    Event Type
    Injury
    Date Received
    November 15, 2019
    Report Date
    October 24, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: HEPATO-GASTROENTEROLOGY. 2007; 54: 503-507. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: LAPAROSCOPIC BILIARY BYPASS - A SINGLE CENTRE EXPERIENCE." AUTHOR : 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 CHOLEDOCHOILEOSTOMY 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
    1121991 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention