BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM TITANIUM LIGATING C

    MDR report key: 1053136 · Received May 19, 2008

    Report

    Report Number
    1527736-2008-03156
    Event Type
    Injury
    Date Received
    May 19, 2008
    Date of Event
    May 1, 2001
    Report Date
    May 2, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A LAPAROSCOPIC CHOLECYSTECTOMY PERFORMED IN 2001. THE PT CAME TO THE DOCTORS OFFICE STATING SHE IS HAVING A REACTION TO THE STAINLESS STEEL CLIPS. THE ACCOUNT DOES NOT KNOW WHAT PRODUCT WAS USED, BUT KNOWS IT WAS AN EES CLIP APPLIER. AS OF NOW THE PT HAS NOT HAD ANY MEDICAL INTERVENTION. THE PT HAS BEEN EXPERIENCING PAIN SINCE HER PROCEDURE IN THE SAME MONTH. SHE HAS UNDERGONE MRI'S AND CT SCANS AND NO ABNORMALITIES HAVE BEEN OBSERVED. THE PT BELIEVES THAT STAINLESS STEEL CLIPS WERE USED AN SHE WOULD LIKE THE DOCTOR TO REMOVE THEM AND PLACE TITANIUM CLIPS. THE DOCTOR IS TRYING TO DETERMINE WHAT TYPES OF CLIP APPLIER WAS USED. THE OP REPORT DID NOT INDICATE ONLY THAT 2 CLIPS WERE PLACED ON THE PT SIDE. THE DOCTOR BELIEVES HE USED A REUSABLE CLIP APPLIER, NOT SURE IF HE USED STAINLESS OR TITANIUM CLIPS. THE PT IS COMING IN FOR BLOOD WORK, HOWEVER SHE HAS TOO MANY OTHER UNRELATED COMPLICATIONS TO GO IN AND REMOVE THE CLIPS (AS THE PT HAS REQUESTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM TITANIUM LIGATING C GDO ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other