BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 1912769 · Received December 2, 2010

    Report

    Report Number
    3005075853-2010-06810
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, A CLIP FELL OUT OF THE DEVICE AFTER IT WAS INTRODUCED THROUGH THE TROCAR. THE CLIP WAS RETRIEVED FROM THE PATIENT THROUGH THE TROCAR. OUTSIDE OF THE PATIENT, IT WAS NOTICED THAT ANOTHER CLIP WOULD NOT ADVANCE INTO THE JAWS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    RESIDENT WAS FOUND WITH LOWER BODY ON FLOOR AND UPPER BODY LEANING AGAINST BED. RESIDENT'S HEAD WAS ON BED ON LEFT SIDE IN BETWEEN MATTRESS AND SIDE RAIL. BED ALARM DID NOT SOUND AS HEAD WAS ON THE BED ALARM SENSOR. MEDICAL EXAMINER EXAMINED PT AND DETERMINED CAUSE OF DEATH TO BE ASPHYXIATION. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: HX OF FALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. G4TZ2J

    Patients

    Seq Age Sex Outcome Treatment
    1 TROCAR