BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 11177263 · Received January 15, 2021

    Report

    Report Number
    1717344-2021-00079
    Event Type
    Injury
    Date Received
    January 15, 2021
    Date of Event
    December 22, 2017
    Report Date
    January 15, 2021
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: SAFETY AND FEASIBILITY OF THE ROBOTIC PLATFORM IN THE MANAGEMENT OF SURGICAL SEQUELAE OF CHRONIC PANCREATITIS: AHMAD HAMAD, 2017, SPRINGER SOURCE: SURGICAL ENDOSCOPY (2018) 32:1056¿1065, HTTPS://DOI.ORG/10.1007/S00464-017-6010-2. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, A STUDY ANALYZED THE SAFETY OF ROBOTIC-ASSISTED RESECTIONS AND/OR DRAINAGE PROCEDURES FOR PATIENTS WITH CHRONIC PANCREATITIS BETWEEN 2009 AND 2017. THERE WERE 39 PATIENTS WHO UNDERWENT THE FOLLOWING PROCEDURES: 11 TOTAL PANCREATECTOMIES 8 PUESTOW PROCEDURES, 4 FREY PROCEDURES, 6 PANCREATICODUODENECTOMIES, AND 10 DISTAL PANCREATECTOMIES. THE LIGASURE WAS USED TO OPEN THE LESSER SAC AND ON VENOUS BRANCHES. THE V-LOC WAS USED FOR THE JEJUNOJEJUNOSTOMY AND THE PANCREATOJEJUNOSTOMY ANASTOMOSIS. POST-OPERATIVE COMPLICATIONS INCLUDE: GI BLEED AT THE JEJUNOJEJUNAL ANASTOMOSIS REQUIRING ENDOSCOPY, EBL UP TO 1000ML, FLUID COLLECTION REQUIRING CT-GUIDED DRAINAGE, PANCREATIC FISTULA REQUIRING ERCP AND 90-DAY READMISSION DUE TO INFECTION OR ABDOMINAL FLUID COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75722 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1