BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK VLOC PRODUCT

    MDR report key: 3657446 · Received November 27, 2013

    Report

    Report Number
    1219930-2013-01017
    Event Type
    Injury
    Date Received
    November 27, 2013
    Report Date
    November 7, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ROUX-EN-Y. LITERATURE REVIEW: AN ARTICLE TITLED: BARBED UNIDIRECTIONAL V-LOC 180 SUTURE IN LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS: A STUDY COMPARING UNIDIRECTIONAL BARBED MONOFILAMENT AND MULTIFILAMENT ABSORBABLE SUTURE IN THE JOURNAL OF SURG ENDOSC (2013) 27:3846.3851 STATS BETWEEN OCTOBER 2009 AND OCTOBER 2012. 239 PATIENTS UNDERGOING ROUX-EN-Y IN GASTRIC BYPASS WERE INCLUDED IN A STUDY OF USING V-LOC 180. IN ONE PT, INTESTINAL BLEEDING WAS OBSERVED AT THE GASTROJEJUNAL ANASTOMOSIS ON POST OP DAY 9. IT WAS TREATED BY LOCAL ADRENALINE INJECTION AND MONOPOLAR ELECROCAUTERY AT ENDOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619511 UNK VLOC PRODUCT V-LOC GAM COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other