BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGUORY NASAL BILIARY DRAINAGE SET

    MDR report key: 10029284 · Received May 6, 2020

    Report

    Report Number
    3001845648-2020-00282
    Event Type
    Injury
    Date Received
    May 6, 2020
    Date of Event
    January 1, 2013
    Report Date
    October 20, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE RPN IS UNKNOWN THE PMA/510(K)# FOR THE ENDB FAMILY IS K180868. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT DUE TO THE REPORTABLE INCIDENT ALREADY BEING COVERED IN MDR REFERENCE # 3001845648-2020-00277

    Description of Event or Problem · 0

    KAWASHIMA ET AL 2013 - PREOPERATIVE ENDOSCOPIC NASOBILIARY DRAINAGE IN 164 CONSECUTIVE PATIENTS WITH SUSPECTED PERIHILAR CHOLANGIOCARCINOMA TO ASSESS THE CLINICAL BENEFITS OF PREOPERATIVE ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) IN PATIENTS WITH PERIHILAR CHOLANGIOCARCINOMA. THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: ENBD (RPN UNKNOWN), ENBD-5 LIGUORY, ENBD-5 LIGUORY-RT, ENBD-7, ENBD-7 LIGUORY-C, ENBD-7-LIGUORY-RT, ENBD-7-NAG-C CUSTOMER REPORTED PRODUCT QUANTITY IS UNKNOWN. AN ADDITIONAL PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE WAS REQUIRED IN 21 (12.8%) OF THE 164 PATIENTS BECAUSE OF POOR DRAINAGE AND/OR CHOLANGITIS THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT DUE TO THE REPORTABLE INCIDENT ALREADY BEING COVERED IN MDR REFERENCE # 3001845648-2020-00277

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. AS THE RPN IS UNKNOWN THE PMA/510(K)# FOR THE ENDB FAMILY IS K180868.

    Description of Event or Problem · 1

    KAWASHIMA ET AL 2013 - PREOPERATIVE ENDOSCOPIC NASOBILIARY DRAINAGE IN 164 CONSECUTIVE PATIENTS WITH SUSPECTED PERIHILAR CHOLANGIOCARCINOMA TO ASSESS THE CLINICAL BENEFITS OF PREOPERATIVE ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) IN PATIENTS WITH PERIHILAR CHOLANGIOCARCINOMA. THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: ENBD (RPN UNKNOWN), ENBD-5 LIGUORY, ENBD-5 LIGUORY-RT, ENBD-7, ENBD-7 LIGUORY-C, ENBD-7-LIGUORY-RT, ENBD-7-NAG-C. CUSTOMER REPORTED PRODUCT QUANTITY IS UNKNOWN. AN ADDITIONAL PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE WAS REQUIRED IN 21 (12.8%) OF THE 164 PATIENTS BECAUSE OF POOR DRAINAGE AND/OR CHOLANGITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491096 LIGUORY NASAL BILIARY DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention