BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FCG KIT, NEEDLE, BIOPSY

    MDR report key: 9932078 · Received April 7, 2020

    Report

    Report Number
    3001845648-2020-00215
    Event Type
    Injury
    Date Received
    April 7, 2020
    Date of Event
    June 12, 2014
    Report Date
    July 20, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS EXACT RPN IS UNKNOWN THEN THIS IS THE LIST OF POTENTIAL 510 K #¿S: K160229, K083330 OR K142688. PLEASE NOTE, DUE TO LIMITED INFORMATION PROVIDED IN THIS LITERATURE, WE CANNOT CONFIRM OF THE ALL POTENTIAL ECHO DEVICES USED, WHICH OF THE FOLLOWING MAY HAVE CAUSED THE ABDOMINAL PAIN, THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: ECHO-HD-22-EBUS-O, OR ECHO-1-22, OR 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. DEVICE EVALUATION: THE UNKNOWN DEVICES OF UNKNOWN LOT NUMBERS INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. REFERENCE "VANBIERVLIET ET AL 2014" COMPLAINT FILES (B)(4) WERE OPENED AS A RESULT OF THIS PAPER. THIS FILE WAS OPENED TO INVESTIGATE FOUR CASES OF ABDOMINAL PAIN REQUIRING ANALGESIC. 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. HOWEVER THERE WAS NO EVIDENCE OF A FAILURE REPORTED ASSOCIATED WITH THE ACTUAL DEVICES. AS PER THE IFU POTENTIAL COMPLICATIONS INCLUDE PAIN. AS PER MEDICAL AFFAIRS "IT WAS PROCEDURE RELATED, THE DEVICE FUNCTIONALITY DID NOT CONTRIBUTE TO THIS COMPLICATION (I.E., THIS PAIN WAS NOT DUE TO THE DEFECTIVE DEVICE) ' SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN, FOUR CASES OF ABDOMINAL PAIN REQUIRING ANALGESICS AS REPORTED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THIS IS A FOLLOW UP REPORT. THE INVESTIGATION IN RELATION TO THIS FILE WAS COMPLETED ON 20TH JULY 2020. RESULTS AND CONCLUSIONS ARE OUTLINED IN SECTION H OF THIS REPORT. TITLE OF LITERATURE REVIEW: 'CORE NEEDLE VERSUS STANDARD NEEDLE FOR ENDOSCOPIC ULTRASOUND-GUIDED BIOPSY OF SOLID PANCREATIC MASSES: A RANDOMIZED CROSSOVER STUDY' VANBIERVLIET ET AL 2014. 4 CASES OF ABDOMINAL PAIN REQUIRING ANALGESICS FOLLOWING THE EUS PROCEDURE WITHOUT ELEVATION OF THE SERUM LIPASE LEVEL (N=4; 5%). THIS FILE IS CREATED TO CAPTURE 4 CASES OF ABDOMINAL PAIN REQUIRING ANALGESICS. PLEASE NOTE, DUE TO LIMITED INFORMATION PROVIDED IN THIS LITERATURE, WE CANNOT CONFIRM OF THE ECHO DEVICES USED, WHICH OF THE FOLLOWING CAUSED THE ABDOMINAL PAIN REQUIRING ANALGESICS, THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: 1. ECHOTIP 22 G FNA NEEDLES COULD INCLUDE: ITF052-EN EBUS NEEDLES: ECHO-HD-22-EBUS-O. OR ITF039-AN ASPIRATION NEEDLES: ECHO-1-22. 2. 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.

    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, K083330 OR K142688. PLEASE NOTE, DUE TO LIMITED INFORMATION PROVIDED IN THIS LITERATURE, WE CANNOT CONFIRM OF THE ALL POTENTIAL ECHO DEVICES USED, WHICH OF THE FOLLOWING MAY HAVE CAUSED THE ABDOMINAL PAIN, THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: ECHO-HD-22-EBUS-O OR ECHO-1-22 OR 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

    TITLE OF LITERATURE REVIEW: 'CORE NEEDLE VERSUS STANDARD NEEDLE FOR ENDOSCOPIC ULTRASOUND-GUIDED BIOPSY OF SOLID PANCREATIC MASSES: A RANDOMIZED CROSSOVER STUDY' VANBIERVLIET ET AL 2014. 4 CASES OF ABDOMINAL PAIN REQUIRING ANALGESICS FOLLOWING THE EUS PROCEDURE WITHOUT ELEVATION OF THE SERUM LIPASE LEVEL (N=4; 5%). THIS FILE IS CREATED TO CAPTURE 4 CASES OF ABDOMINAL PAIN REQUIRING ANALGESICS. PLEASE NOTE, DUE TO LIMITED INFORMATION PROVIDED IN THIS LITERATURE, WE CANNOT CONFIRM OF THE ECHO DEVICES USED, WHICH OF THE FOLLOWING CAUSED THE ABDOMINAL PAIN REQUIRING ANALGESICS, THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: ECHOTIP 22 G FNA NEEDLES COULD INCLUDE: ITF052-EN EBUS NEEDLES: ECHO-HD-22-EBUS-O OR ITF039-AN ASPIRATION NEEDLES: ECHO-1-22. 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
    395818 FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention