BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 9932679 · Received April 7, 2020

    Report

    Report Number
    3001845648-2020-00236
    Event Type
    Injury
    Date Received
    April 7, 2020
    Date of Event
    March 20, 2012
    Report Date
    May 27, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    510K # - K142688. PLEASE NOTE THIS REPORT WILL UPDATE THE RPN TO ECHO-HD-22-C. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    510K # - K142688. THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RPN OF THE DEVICE CHANGING FROM UNKNOWN TO ECHO-HD-22-C. DEVICE EVALUATION: THE ECHO-HD-22-C DEVICE 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 "BANG ET AL 2012" TO INVESTIGATE MILD ACUTE PANCREATITIS THAT REQUIRED HOSPITALIZATION FOR 2 DAYS. LAB EVALUATION ¿ N/A. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE ECHO-HD-22-C DEVICE OF UNKNOWN LOT NUMBER, 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. AS THE ECHO-HD-22-C DEVICE FROMUNKNOWN 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. IMAGE REVIEW ¿ N/A. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. HOWEVER THERE WAS NO EVIDENCE OF A FAILURE REPORTED ASSOCIATED WITH THE ACTUAL DEVICES. AS PER THE IFU POTENTIAL COMPLICATIONS INCLUDE ACUTE PANCREATITIS. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN, MILD ACUTE PANCREATITIS THAT REQUIRED HOSPITALIZATION FOR 2 DAYS AS REPORTED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. ATTACHMENT: [BANG ET AL 2012.PDF].

    Description of Event or Problem · 0

    PLEASE NOTE THIS REPORT WILL UPDATE THE RPN TO ECHO-HD-22-C.

    Description of Event or Problem · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RPN OF THE DEVICE CHANGING FROM UNKNOWN TO ECHO-HD-22-C.

    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 K142688. PLEASE NOTE, DUE TO LIMITED INFORMATION PROVIDED IN THIS LITERATURE, WE CANNOT CONFIRM OF THE ECHO DEVICES USED, WHICH OF THE FOLLOWING CAUSED THE MILD ACUTE PANCREATITIS , THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: 22 G FNB NEEDLE (ECHOTIP PRO CORE) COULD INCLUDE: ECHO-HD-22-EBUS-O - C OR ECHO-HD-22-C. 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

    AS REPORTED TO CUSTOMER RELATIONS VIA LITERATURE ARTICLE: TITLE OF LITERATURE REVIEW: 'RANDOMIZED TRIAL COMPARING THE 22-GAUGE ASPIRATION AND 22-GAUGE BIOPSY NEEDLES FOR EUS-GUIDED SAMPLING OF SOLID PANCREATIC MASS LESIONS' BANG ET AL 2012. 'ONLY 2 PATIENTS IN THE ENTIRE COHORT HAD COMPLICATIONS: 1 PATIENT (3.6%) IN THE FNA GROUP HAD POSTPROCEDURAL ABDOMINAL PAIN THAT WAS MANAGED CONSERVATIVELY ON AN OUTPATIENT BASIS, AND 1 PATIENT (3.6%) IN THE FNB COHORT DEVELOPED MILD ACUTE PANCREATITIS THAT REQUIRED HOSPITALIZATION FOR 2 DAYS'. THIS FILE IS CREATED TO CAPTURE 1 PATIENT (3.6%) IN THE FNB COHORT DEVELOPED MILD ACUTE PANCREATITIS THAT REQUIRED HOSPITALIZATION FOR 2 DAYS'. PLEASE NOTE, DUE TO LIMITED INFORMATION PROVIDED IN THIS LITERATURE, WE CANNOT CONFIRM OF THE ECHO DEVICES USED, WHICH OF THE FOLLOWING CAUSED THE MILD ACUTE PANCREATITIS , THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: 22 G FNB NEEDLE (ECHOTIP PRO CORE) COULD INCLUDE: ITF052-EN EBUS NEEDLES: ECHO-HD-22-EBUS-O - C OR ITF039-AN ASPIRATION NEEDLES: ECHO-HD-22-C. 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
    396971 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization