BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 81899 · Received March 14, 1997

    Report

    Report Number
    1527736-1997-00266
    Event Type
    Injury
    Date Received
    March 14, 1997
    Date of Event
    February 7, 1997
    Report Date
    March 13, 1997
    Manufacturer
    EES-ALBUQUERQUE
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED POST-OPERATIVELY OF A LAPAROSCOPIC CHOLECYSTECTOMY THE CYSTIC ARTERY BLED. THE ER320 USED IN THE CASE DID NOT SEEM TO MALFUNCTION AT THE TIME. THE PATIENT HAS ASKED THE HOSPITAL FOR MEDICAL RECORDS. THE SURGEON PROVIDED NO FURTHER INFORMATION. RPO 2/21/97 RECEIVED MEDWATCH WITHOUT NUMBER STATING "INTRA-ABDOMINAL BLEEDING POST LAPAROSCOPIC CHOLECYSTECTOMY DUE TO QUESTIONABLE FAULTY CLIP. CO USED DISPOSABLE ENDOSCOPIC ROTATING CLIP APPLIER AND CLIPS." CLINICAL FOLLOW-UP: 2/17/97 1622 MESSAGE AND 800# LEFT ON RISK MANAGER'S PM REQUESTING FOLLOW UP. 2/21/97 0945 RISK MANAGER CALLED BACK AND STATED SHE HAS INVESTIGATED THE EVENT AND WILL SEND MEDWATCH UPON COMPLETION. SHE STATED THE PATIENT WAS RE-OPERATED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO EES-ALBUQUERQUE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization