BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 166025 · Received May 1, 1998

    Report

    Report Number
    1527736-1998-01323
    Event Type
    Malfunction
    Date Received
    May 1, 1998
    Date of Event
    April 1, 1998
    Report Date
    April 2, 1998
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.51057. EES #.982373. D5,6; H4: INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ER220 WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE DEVICE WAS USED ACROSS THE CYSTIC DUCT AND THE STAPLES WERE MALFORMED. ANOTHER ER220 WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other