BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIPRO* 4/0 36 BLUE CV-25 D/A

    MDR report key: 4460850 · Received January 28, 2015

    Report

    Report Number
    9612501-2015-00063
    Event Type
    Injury
    Date Received
    January 28, 2015
    Date of Event
    December 30, 2014
    Report Date
    January 2, 2015
    Manufacturer
    COVIDIEN
    Product Code
    GAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP SENT TO FDA ON 03/24/2015.

    Description of Event or Problem · 1

    PROCEDURE: ABDOMINAL AORTIC ANEURYSM THE CUSTOMER STATES THAT PREMATURE BREAKAGE OF THE SUTURE STRAND OCCURED DURING AN URGENT ABDOMINAL ANEURYSM. ISSUE SOLVED BY USING A NEW SUTURE. (IF THE PRODUCT WAS USED ON A PATIENT). 1. PERSON INJURED OR JEOPARDIZED NO. 2. OF THE SURGERY TIME BY MORE THAN 30 MIN. OR RE-OPERATION NECESSARY - YES. 3. BLOOD LOSS OF MORE THAN 250CC - NO. 4. EXTENSION OF THE INCISION BY MORE THAN 1 INCH - NO. 5. CHANGE FROM ENDOSCOPIC TO OPEN SURGERY - YES/NO). 6. UNANTICIPATED TISSUE LOSS OR IRREVERSIBLE DAMAGE - YES. 7. ANY PORTION OF THE DEVICE OR TACK FALL INTO THE PATIENT CAVITY - NO. 8. WAS ANY REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE? NO. NGE FROM ENDOSCOPIC TO OPEN SURGERY? NO, NOT APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63988 SURGIPRO* 4/0 36 BLUE CV-25 D/A SURGIPRO* 4/0 GAW COVIDIEN VP761X T1F0096B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other