BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 158138 · Received March 20, 1998

    Report

    Report Number
    1527736-1998-00798
    Event Type
    Injury
    Date Received
    March 20, 1998
    Date of Event
    January 14, 1998
    Report Date
    February 19, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.49799. EES #.981269/A. THE PT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY IN 1/1998 AND ONE WEEK POST OPERATIVELY DEVELOPED BILE PERITONITIS. THEY WERE UNABLE TO PLACE A STENT IN THE LOCAL HOSP AND THE PT WAS SENT TO ANOTHER INSTITUTION WHERE THE STENT WAS PLACED. "ERCP" REVEALED A LEAK FROM THE END OF THE DUCT. A CLIP WAS PRESENT BUT MAY NOT HAVE BEEN COMPLETELY CLOSED. LATER THE PT REQUIRED EXPLORATORY LAPROTOMY WITH DRAINAGE OF A LESSER SAC ABSCESS. CO DISCUSSED PROPER TECHNIQUE IN APPLYING CLIPS. THE PHYSICIAN STATES THE HOSP TESTS THE CLIP APPLIER BY FIRING THE CLIP ON A TOWEL PRIOR TO ITS USE. FACILITY EXPLAINED THAT THIS WAS SOMETHING CO HAD NOT VALIDATED AND COULD NOT RECOMMEND. SPECIFICALLY, FACILITY INDICATED THAT FIRING THE INSTRUMENT IN AN INAPPROPRIATE FASHION COULD LEAD TO DAMAGED JAWS AND NON FUNCTIONAL CLIPS.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER A LAPAROSCOPIC CHOLECYSTECTOMY THE PT HAD POST-OP DISCOMFORT. AN ERCP FAILED TWO TIMES DUE TO "ANATOMICAL LIMITATIONS." THE PT WAS SENT TO THE MEDICAL CENTER FOR AN EVALUATION AND STENT. THE DRS AT MEDICAL CENTER SAID THE CYSTIC DUCT WAS LEAKING BILE DUE TO FAILURE OF THE CLIPS BETWEEN THE CYSTIC DUCT AND COMMON DUCT. THE SURGEON AND TECH MENTIONED THAT THE CLIPS WERE THE ANODIZED BLUE COLOR NOT THE NORMAL SILVER TITANIUM FINISH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R