BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP** ENDOSCOPIC

    MDR report key: 2861832 · Received December 7, 2012

    Report

    Report Number
    3005075853-2012-05503
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    November 21, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THIS A TRADITIONAL CHOLECYSTECTOMY APPROACH OR SOME OTHER VARIANT SUCH AS SINGLE SITE? TRADITIONAL CHOLECYSTECTOMY HOW MANY CLIPS WERE APPLIED DURING THE INITIAL PROCEDURE? BOTH TOTAL AND SPECIFIC TO THE CYSTIC ARTERY AND CYSTIC DUCT? FOUR IN THE CYSTIC (3 ON PATIENT SIDE AND 1 ON THE CHOLE SIDE) AND 3 IN THE ARTERY(2 IN THE PATIENT SIDE). WAS THE CLIP FULLY ADVANCED INTO THE JAWS? WAS THERE ANY ISSUE RELATED TO LOADING OF THE CLIP DURING OR PRIOR TO THE "NOT COMPLETELY CLOSED CLIP?" FULLY ADVANCED, BUT THE PROBLEM THAT THE SURGEON TOLD IS THAT WHEN SHE APPLIED THE SECOND CLIP, SHE OBSERVED THAT THE FIRST ONE ON THE CYSTIC WAS MALFORMED, SO SHE TRIED TO PULL THE CLIP OUT, BUT COULDN'T. THAT'S WHY SHE DELIVERED ANOTHER CLIP ON THE PATIENT SIDE DISTALLY FROM THE BODY. DID THE PROCEDURE DRIVE THE NEED TO APPLY TORQUE OR TWISTING OF THE DEVICE? ESPECIALLY FOR THE MALFORMED CLIPS? YES, EXPLAINED ABOVE. AS AN ADDITION THE SURGEON TOLD THAT PROBABLY THE LEAKAGE WAS FROM THE ATTEMPT TO PULL THE FIRST CLIP OUT. DURING THE RE-OP SHE OBSERVED THAT THE LEAKAGE WAS SIZED AS A NEEDLE HOLE ON THE UNDER SIDE OF THE FIRST CLIP. WAS THE DEVICE FIRED ON A HARD OBJECT (E.G. A CLIP)? WAS AN INTRAOPERATIVE CHOLANGIOGRAM PERFORMED? ALSO CAN ASK ABOUT IT SHE UTILIZES THIS TO POSITION THE CHOLANGIOGRAM TUBE? NO. WHAT VESSEL WAS THE DEVICE FIRED ON? PLEASE SPECIFY THE SIZE OF THE VESSEL. CYSTIC DUCT WHAT STEPS WERE TAKEN AFTER THE SURGEON OBSERVED INADEQUATE CLIP CLOSURE DURING THE INITIAL PROCEDURE? THE ER320 HAD AN ISSUE (WAS IT SCISSORING?, TOO LARGE OF CLIP GAP?); WHAT FIRING WAS THIS OBSERVED? THE FIRST CLIP ON THE CYSTIC DUCT. WAS TOO LOOSE. DID THE SURGEON USE LT300 CLIPS DURING THE INITIAL PROCEDURE FOR THIS PATIENT? NO. WAS THE SURGEON ABLE TO VISUALIZE PROPER CLIP FORMATION PRIOR TO CLOSING THE PATIENT DURING THE INITIAL PROCEDURE? YES. HOW MANY HOURS OR DAYS POST OPERATIVE DID THE PATIENT UNDERGO THE REOPERATION? WHAT IS THE TIMING OF THIS (INTRAOP LEAKAGE, POST OP LEAKAGE?) SEVEN DAYS AFTER THE FIRST ONE WHAT WAS FOUND DURING THE REOPERATION? WAS THIS A BILE LEAK? IF SO HOW WAS THIS TREATED (ERCP, DRAIN, SURGICAL EXPLORATION)..BILE LEAK. SURGICAL TREATED WITH SUTURE, CLIP(LT300) POST OPERATIVE WITH DRAIN FOR 3 DAYS. CAN YOU DESCRIBE THE CLIP FORMATION OF THE ER320 CLIPS AND IF APPLICABLE THE CLIP FORMATION OF THE LT300 CLIPS? THEN THE LT300 WAS UTILIZED WITH OR WITHOUT ISSUE? NO LT300 WAS UTILIZED, ONLY THE PERMANENT DEVICE TO BETTER CLOSE THE CLIPS FORMED WITH THE ER320. THE CLIPS WERE MALFORMED, SPECIFICALLY THEY WERE A LITTLE OPENED DISTALLY. WHAT WERE THE PATIENT'S PRE-EXISTING CONDITIONS? WHAT WAS THE INDICATION FOR SURGERY (ACUTE CHOLECYSTITIS)?. CHOLELITHIASIS PATIENT'S SEX, AGE, AND WEIGHT? FEMALE (B)(6). WHAT IS THE PATIENT'S CURRENT STATUS? TOTALLY RECOVERED. IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? YES. HOW LONG HAS THE SURGEON BEEN USING THE ER320 DEVICE? WAS THIS POTENTIALLY REPROCESSED? THE SURGEON IS EXPERIENCED ON THE DEVICE AND IT WAS NOT REPROCESSED. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHE HAD TO PERFORM A RE-OPERATION ON THE PATIENT THAT WAS SUBMITTED TO A CHOLECYSTECTOMY, BECAUSE THE CLIP OF THE DEVICE DID NOT CLOSE PROPERLY ON THE PATIENT'S SIDE, CAUSING INFLAMMATION AND LEAKAGE OF PUS INTO THE ABDOMINAL CAVITY. THE PROBLEM DESCRIBED BY THE DOCTOR IS THAT THE DEVICE DID NOT COMPLETELY CLOSE THE CLIP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention