BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN-VLOC PRODUCT

    MDR report key: 11147696 · Received January 11, 2021

    Report

    Report Number
    1219930-2021-00099
    Event Type
    Injury
    Date Received
    January 11, 2021
    Date of Event
    August 19, 2020
    Report Date
    January 11, 2021
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: ROBOTIC-ASSISTED PANCREATICODUODENECTOMY WITH VASCULAR RESECTION. DESCRIPTION OF THE SURGICAL TECHNIQUE AND ANALYSIS OF EARLY OUTCOMES SOURCE: SURGICAL ONCOLOGY 35 (2020) 344¿350, HTTPS://DOI.ORG/10.1016/J.SURONC.2020.08.025. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN 2013 AND 2019, SUTURE WAS USED TO RECONSTRUCTION OF THE PANCREATOJEJUNOSTOMY TO SUTURE TO SECURE THE PANCREATIC PARENCHYMA TO THE JEJUNUM DURING ROBOTIC PANCREATICODUODENECTOMY WITH SUPERIOR MESENTERIC-PORTAL VEIN RESECTION AND RECONSTRUCTION. POSTOPERATIVELY, THE FOLLOWING COMPLICATIONS WERE REPORTED: BIOCHEMICAL LEAKS, BLOOD LOSS UP TO 689ML, REOPERATIONS (ONE WHICH WAS DUE TO THE DISASSEMBLY OF PANCREATICO-JEJUNOSTOMY), POST-PANCREATECTOMY HEMORRHAGE, AND INTRAPERITONEAL FLUID COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43127 UNKNOWN-VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN-VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention