BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9637982 · Received January 28, 2020

    Report

    Report Number
    2210968-2020-00753
    Event Type
    Injury
    Date Received
    January 28, 2020
    Report Date
    January 8, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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: JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES (2013); 3(3): 211-215. DOI: 10.1089/LAP.2012.0303. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE"TITLE: LAPAROSCOPIC CHOLEDOCHOLITHOTOMY WITH RIGID NEPHROSCOPE". AUTHORS: RAJEEV SINHA, MS, FICS, FAIS. CITATION: JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES (2013); 3(3): 211-215. DOI: 10.1089/LAP.2012.0303. APART FROM THE REQUIRED EXPERTISE, A MAJOR DETERRENT TO LAPAROSCOPIC COMMON BILE DUCT (CBD) LITHOTOMY (LCDL) REMAINS THE RELATIVELY PROHIBITIVE COST OF THE FLEXIBLE CHOLEDOCHOSCOPE, AND IT ALSO HAS A SHORTCOMING OF NOT BEING EFFECTIVE IN REMOVAL OF LARGE IMPACTED CBD STONES. THIS STUDY INVOLVES 172 CONSECUTIVE PATIENTS (19 MALES; AGE RANGE: 13 TO 78 YEARS) WITH CBD STONES WHO WERE TREATED WITH TRANSDOCHAL LCDL FROM JANUARY 2002 TO MAY 2012. DURING THE PROCEDURE, THE ANTERIOR SURFACE OF THE COMMON BILE DUCT (CBD) WAS CLEARED OFF THE ANTERIOR LEAF OF THE VISCERAL PERITONEUM USING A HARMONIC SCALPEL (ETHICON). AFTER THOROUGH FLUSHING AND ENSURING TOTAL CLEARANCE OF THE CBD, BY VISUALIZING ITS AMPULLARY END, THE CBD WAS CLOSED WITHOUT A STENT, WITH CONTINUOUS 3-0 POLYGLACTIN ACID (VICRYL; ETHICON) SUTURING. REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE MILD ACUTE PANCREATITIS (N-?) WHICH RESPONDED TO CONSERVATIVE TREATMENT AND RESOLVED COMPLETELY WITHIN A WEEK, AND BILIARY PERITONITIS (N-?) WHICH RESPONDED TO CONSERVATIVE TREATMENT AND RESOLVED CONSERVATIVELY. IN CONCLUSION, RIGID SCOPE TRANSDOCHAL LCDL IS FEASIBLE, PROBABLY EASIER, BETTER FOR IMPACTED LARGE CBD STONES, AND DEFINITELY MORE AFFORDABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101561 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention