BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP*ENDO

    MDR report key: 7855100 · Received September 7, 2018

    Report

    Report Number
    3005075853-2018-12552
    Event Type
    Injury
    Date Received
    September 7, 2018
    Report Date
    August 24, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH #UNK. AS A LOT/BATCH WAS NOT PROVIDED, A DEVICE HISTORY COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE : AN AUDIT OF CYSTIC DUCT CLOSURE IN LAPAROSCOPIC CHOLECYSTECTOMIES. AUTHOR: A. ROHATGI, A.L. WIDDISON. CITATION: SURG ENDOSC. 2006; 20: 875¿877. DOI: 10.1007/S00464-004-2253-9. CYSTIC DUCT LEAK IS AN INFREQUENT BUT POTENTIALLY SERIOUS COMPLICATION OF LAPAROSCOPIC CHOLECYSTECTOMY. THE AIM OF THIS AUDIT WAS TO ASSESS THE EFFICACY OF LOCKING ABSORBABLE CLIPS FOR CLOSING THE CYSTIC DUCT AND TO COMPARE THE RESULTS WITH THOSE FOR SIMPLE CLIPS USED PREVIOUSLY. A TOTAL OF 494 PATIENTS UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMIES AND WERE INCLUDED IN THE STUDY. OF WHICH, 346 PATIENTS (AGE RANGE: 20 TO 86 YEARS OLD) WERE RANDOMIZED UNDER LAPROCLIPS AND 148 PATIENTS (AGE RANGE: 17 TO 84 YEARS OLD) WERE RANDOMIZED UNDER LIGACLIPS. IT WAS REPORTED THAT UNTIL 1998, SIMPLE CLIPS WERE USED TO CLOSE THE CYSTIC DUCT ROUTINELY. THE SIMPLE CLIPS USED WERE U-SHAPED PIECES OF LIGACLIP TITANIUM (ETHICON) WHICH WERE TIGHTLY CLOSED AROUND THE DUCT USING A 10-MM APPLICATOR. USUALLY 3 LARGE CLIPS WERE APPLIED, AND THE CYSTIC DUCT WAS TRANSACTED BETWEEN THE PROXIMAL AND MIDDLE CLIPS. IN THE LIGACLIPS GROUP, REPORTED COMPLICATIONS INCLUDED CYSTIC DUCT CLOSURE FAILURE (N-2) IN WHICH THE DUCTS WERE CLOSED WITH EITHER ENDOLOOP OR A SUTURE, BILOMA (N-2) WHICH RESPONDED TO PERCUTANEOUS DRAINAGE, AND CYSTIC DUCT LEAK (N-3) WHICH REQUIRED SUTURE LIGATION AT LAPAROTOMY (N-1) AND PERCUTANEOUS DRAINAGE AND ENDOSCOPIC STENTING (N-2). IT WAS CONCLUDED THAT ABSORBABLE LOCKING CLIPS SHOULD BE USED ROUTINELY TO CLOSE THE CYSTIC DUCT IN PREFERENCE TO SIMPLE TITANIUM CLIPS. ABSORBABLE LOCKING CLIPS ARE EASY TO APPLY, MORE SECURE, ASSOCIATED WITH FEWER CYSTIC DUCT LEAKS. THEY ALSO CAUSE LESS INFLAMMATORY REACTION, AND DO NOT MIGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698884 LIGACLIP*ENDO CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1