BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 11176704 · Received January 15, 2021

    Report

    Report Number
    9612501-2021-00080
    Event Type
    Injury
    Date Received
    January 15, 2021
    Date of Event
    December 22, 2017
    Report Date
    January 15, 2021
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: SAFETY AND FEASIBILITY OF THE ROBOTIC PLATFORM IN THE MANAGEMENT OF SURGICAL SEQUELAE OF CHRONIC PANCREATITIS SOURCE: SURGICAL ENDOSCOPY (2018) 32:1056¿1065 / PUBLISHED ONLINE: 22 DECEMBER 2017. 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 SUTURE 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. TITLE: SAFETY AND FEASIBILITY OF THE ROBOTIC PLATFORM IN THE MANAGEMENT OF SURGICAL SEQUELAE OF CHRONIC PANCREATITIS: AHMAD HAMAD, 2017, SPRINGER AUTHORS: HAMAD A, ZENATI MS, NGUYEN TK, HOGG ME, ZEH HJ 3RD, ZUREIKAT AH YEAR: 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76130 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM DAVIS & GECK CARIBE LTD UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1