BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FCG KIT, NEEDLE, BIOPSY

    MDR report key: 9930966 · Received April 6, 2020

    Report

    Report Number
    3001845648-2020-00217
    Event Type
    Injury
    Date Received
    April 6, 2020
    Date of Event
    March 6, 2013
    Report Date
    April 30, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS EXACT RPN IS UNKNOWN THEN THIS IS THE LIST OF POTENTIAL 510 K #¿S: K160229 OR K083330. PLEASE NOTE, DUE TO LIMITED INFORMATION PROVIDED IN THIS LITERATURE, WE CANNOT CONFIRM OF THE ECHO DEVICES USED, WHICH OF THE FOLLOWING CAUSED THE 1 CASE OF PANCREATITIS, THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: ECHO-HD-25-EBUS-O (K160229) OR ECHO-25 (K083330) AS PER 'MEDICAL DEVICE REPORTING FOR MANUFACTURER'S (2016), SECTION 4.16.2 'SUBMIT AN INDIVIDUAL REPORT FOR EACH DEVICE IDENTIFIED IF THE GENERIC NAMES OF THE DEVICES ARE DIFFERENT.' THEREFORE, ONE REPORT WILL BE SUBMITTED IN RELATION TO THE ABOVE SERIOUS INJURY. DEVICE EVALUATION THE UNKNOWN DEVICES OF UNKNOWN LOT NUMBERS INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. REFERENCE "LEE ET AL 2013" COMPLAINT FILES (B)(4) WERE OPENED AS A RESULT OF THIS PAPER. THIS FILE (B)(4) WAS OPENED TO INVESTIGATE ONE CASE OF MILD PANCREATITIS. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ECHO DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS THE ECHO DEVICES FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. AS PER THE INSTRUCTIONS FOR USE, IFU0077-4 WHICH INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS "THOSE ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION, HEMORRHAGE, ASPIRATION, FEVER, INFECTION, ALLERGIC REACTION TO MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST, DAMAGE TO BLOOD VESSELS, NERVE DAMAGE, AND ACUTE PANCREATITIS. THOSE ASSOCIATED WITH EUS NEEDLE BIOPSY INCLUDE BUT ARE NOT LIMITED TO: PAIN, DEATH, PERITONITIS, PORTAL VEIN GAS AND THROMBOSIS, PNEUMOPERITONEUM AND TUMOR SEEDING OF THE NEEDLE TRACT. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. AS PER THE IFU POTENTIAL COMPLICATIONS INCLUDE ACUTE PANCREATITIS. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. - ATTACHMENT: [LEE ET AL 2013.PDF]

    Description of Event or Problem · 0

    TITLE: A PROSPECTIVE, RANDOMIZED TRIAL COMPARING 25-GAUGE AND 22-GAUGE NEEDLES FOR ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION OF PANCREATIC MASSES - LEE ET AL 2013 AIM: IN THIS RANDOMIZED TRIAL, THE AUTHORS TRIED TO COMPARE PROSPECTIVELY 25G AND 22G IN DIAGNOSTIC ACCURACY, MANIPULABILITY FROM THE OPERATORS VIEWPOINTS AND PROCEDURE RELATED COMPLICATIONS. ACCORDING TO THE RESULTS, THE OVERALL COMPLICATION DEVELOPED (B)(3) PATIENTS AND THE RATE WAS SOMEWHAT HIGHER THAN THOSE REPORTED IN PREVIOS STUDIES. TABLE V. SHOWS THESE 3 COMPLICATIONS THAT OCCURED IN THE 25G ECHOTIP GROUP- 1 OF WHICH WAS PANCREATITIS AND 2 OF WHICH WERE BLEEDING. ***THIS FILE IS CREATED TO CAPTURE 1 CASES OF PANCREATITIS*** PLEASE NOTE, DUE TO LIMITED INFORMATION PROVIDED IN THIS LITERATURE, WE CANNOT CONFIRM OF THE ECHO DEVICES USED, WHICH OF THE FOLLOWING CAUSED THE 1 CASE OF PANCREATITIS, THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: ECHO-HD-25-EBUS-O OR ECHO-25 AS PER 'MEDICAL DEVICE REPORTING FOR MNAUFACTURER'S (2016), SECTION 4.16.2 'SUBMIT AN INDIVIDUAL REPORT FOR EACH DEVICE IDENTIFIED IF THE GENERIC NAMES OF THE DEVICES ARE DEFFERENT.' THEREFORE, ONE REPORT WILL BE SUBMITTED IN RELATION TO THE ABOVE SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. AS EXACT RPN IS UNKNOWN THEN THIS IS THE LIST OF POTENTIAL 510 K #¿S: K160229 OR K083330. PLEASE NOTE, DUE TO LIMITED INFORMATION PROVIDED IN THIS LITERATURE, WE CANNOT CONFIRM OF THE ECHO DEVICES USED, WHICH OF THE FOLLOWING CAUSED THE 1 CASE OF PANCREATITIS, THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: ECHO-HD-25-EBUS-O (K160229) OR ECHO-25 (K083330). AS PER 'MEDICAL DEVICE REPORTING FOR MANUFACTURER'S (2016), SECTION 4.16.2 'SUBMIT AN INDIVIDUAL REPORT FOR EACH DEVICE IDENTIFIED IF THE GENERIC NAMES OF THE DEVICES ARE DIFFERENT.' THEREFORE, ONE REPORT WILL BE SUBMITTED IN RELATION TO THE ABOVE SERIOUS INJURY.

    Description of Event or Problem · 1

    TITLE: A PROSPECTIVE, RANDOMIZED TRIAL COMPARING 25-GAUGE AND 22-GAUGE NEEDLES FOR ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION OF PANCREATIC MASSES - LEE ET AL 2013. AIM: IN THIS RANDOMIZED TRIAL, THE AUTHORS TRIED TO COMPARE PROSPECTIVELY 25G AND 22G IN DIAGNOSTIC ACCURACY, MANIPULABILITY FROM THE OPERATORS VIEWPOINTS AND PROCEDURE RELATED COMPLICATIONS. ACCORDING TO THE RESULTS, THE OVERALL COMPLICATION DEVELOPED IN13 (6.9%) OUT OF 188 PATIENTS AND THE RATE WAS SOMEWHAT HIGHER THAN THOSE REPORTED IN PREVIOUS STUDIES. TABLE V. SHOWS THESE 3 COMPLICATIONS THAT OCCURED IN THE 25G ECHOTIP GROUP- 1 OF WHICH WAS PANCREATITIS AND 2 OF WHICH WERE BLEEDING. THIS FILE IS CREATED TO CAPTURE 1 CASES OF PANCREATITIS. PLEASE NOTE, DUE TO LIMITED INFORMATION PROVIDED IN THIS LITERATURE, WE CANNOT CONFIRM OF THE ECHO DEVICES USED, WHICH OF THE FOLLOWING CAUSED THE 1 CASE OF PANCREATITIS, THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: ECHO-HD-25-EBUS-O OR ECHO-25. AS PER 'MEDICAL DEVICE REPORTING FOR MANUFACTURER'S (2016), SECTION 4.16.2 'SUBMIT AN INDIVIDUAL REPORT FOR EACH DEVICE IDENTIFIED IF THE GENERIC NAMES OF THE DEVICES ARE DIFFERENT.' THEREFORE, ONE REPORT WILL BE SUBMITTED IN RELATION TO THE ABOVE SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392205 FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention