BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP ALLPORT ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 1101786 · Received August 5, 2008

    Report

    Report Number
    3005075853-2008-00902
    Event Type
    Injury
    Date Received
    August 5, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 11, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    OCW
    PMA / PMN Number
    K934174
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 8/5/08. EVAL SUMMARY: THE ANALYSIS RESULTS OF THE AL326 FOUND THAT THE INSTRUMENT WAS RECEIVED WITH THE JAWS DISLODGED. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLE PROCEDURE, THE TIP BROKE OFF AND FELL INTO THE PT. THE PROCEDURE WAS CONVERTED TO OPEN TO REMOVE THE TIP. THE PT IS OKAY AND THE HOSP STAY WILL NOT BE EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ALLPORT ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER OCW ETHICON ENDO-SURGERY, LLC NA V42X7X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other