BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK-CORE ULTRASOUND BIOPSY NEEDLE

    MDR report key: 7844317 · Received September 4, 2018

    Report

    Report Number
    1037905-2018-00393
    Event Type
    Injury
    Date Received
    September 4, 2018
    Date of Event
    January 1, 2015
    Report Date
    August 10, 2018
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE REFERENCE: NA, H. K., LEE, J. H., PARK, Y. S., AHN, J. Y., CHOI, K.-S., KIM, D. H., ¿ KIM, J.-H. (2015). YIELDS AND UTILITY OF ENDOSCOPIC ULTRASONOGRAPHY-GUIDED 19-GAUGE TRUCUT BIOPSY VERSUS 22-GAUGE FINE NEEDLE ASPIRATION FOR DIAGNOSING GASTRIC SUBEPITHELIAL TUMORS. CLINICAL ENDOSCOPY, 48(2), 152¿157. HTTP://DOI.ORG/10.5946/CE.2015.48.2.152. CONTINUED FROM DATE OF EVENT: 2015. CONTINUED FROM COMMON NAME AND PRODUCT CODE: COMMON NAME-SET, BIOPSY NEEDLE AND NEEDLE GASTRO-UROLOGY; PROCODE- 78FCG. CONTINUED FROM PMA/510(K): K013356. CONTINUED FROM EVENT AND PROBLEM AND EVALUATION CODES: METHOD CODE- 4115 DEVICE DISCARDED. CONTINUED FROM EVENT AND PROBLEM AND EVALUATION CODES: CONCLUSION CODE- 4315 CAUSE NOT ESTABLISHED. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE PRODUCT LINE FOR EUSN-19-QC WAS OBSOLETE IN 2012. THE INSTRUCTIONS FOR USE UNDER POTENTIAL COMPLICATIONS STATES, "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." PRIOR TO DISTRIBUTION, ALL QUICK-CORE ULTRASOUND BIOPSY NEEDLE WERE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED UNUSUAL. NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME BECAUSE THE REFERENCE PART NUMBER: (RPN), EUSN-19-QC, WAS OBSOLETED MARCH 21, 2012 VIA CHANGE REQUEST 12-152-EUSN. THE EUSN-19-QC IS A SINGLE USE DISPOSABLE DEVICE WITH A 3 YEAR EXPIRATION DATE THEREFORE ALL DEVICES DISTRIBUTED ARE BEYOND THEIR EXPECTED LIFE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 0

    DURING TWO ENDOSCOPIC ULTRASONOGRAPHY (EUS) PROCEDURES, THE PHYSICIAN USED TWO COOK QUICK-CORE ULTRASOUND BIOPSY NEEDLES DESCRIBED IN THE BELOW EXCERPT OF CLINICAL STUDY BASED ON THE RECORDS OF PATIENTS FROM NOVEMBER 2005 AND MAY 2012. " ALL ADVERSE EVENTS IMPROVED DURING THE 24-HOUR POST PROCEDURE HOSPITAL STAY. ONE CASE OF TCB [TRUCUT BIOPSY] RELATED ABDOMINAL PAIN RESOLVED SPONTANEOUSLY AND TWO CASES OF IMMEDIATE BLEED AFTER TCB PUNCTURE WERE MANAGED WITH ENDOSCOPIC HEMOSTASIS (SUBJECT OF THIS REPORT)." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE BLEED WAS TREATED WITH ENDOSCOPIC HEMOSTASIS. IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE, BUT NO ADVERSE EFFECTS WERE REPORTED IN THE PUBLISHED CLINICAL STUDY.

    Additional Manufacturer Narrative · 1

    COMMON NAME AND PRODUCT CODE: COMMON NAME-SET, BIOPSY NEEDLE AND NEEDLE GASTRO-UROLOGY; PROCODE- 78FCG. PMA/510(K): K013356. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP EMDR WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING TWO ENDOSCOPIC ULTRASONOGRAPHY (EUS) PROCEDURES, THE PHYSICIAN USED TWO COOK QUICK-CORE ULTRASOUND BIOPSY NEEDLES. THERE WERE IMMEDIATE BLEEDS AFTER TCB [TRUCUT BIOPSY] PUNCTURES AND WERE MANAGED WITH ENDOSCOPIC HEMOSTASIS. NA, H. K., LEE, J. H., PARK, Y. S., AHN, J. Y., CHOI, K.-S., KIM, D. H., ¿ KIM, J.-H. (2015). YIELDS AND UTILITY OF ENDOSCOPIC ULTRASONOGRAPHY-GUIDED 19-GAUGE TRUCUT BIOPSY VERSUS 22-GAUGE FINE NEEDLE ASPIRATION FOR DIAGNOSING GASTRIC SUBEPITHELIAL TUMORS. CLINICAL ENDOSCOPY, 48(2), 152¿157. HTTP://DOI.ORG/10.5946/CE.2015.48.2.152. FURTHER INFORMATION ON THE PATIENT (S) OUTCOME IS NOT AVAILABLE AS THE INFORMATION PROVIDED IS FROM A CLINICAL STUDY BASED ON THE RECORDS OF PATIENTS FROM NOVEMBER 2005 AND MAY 2012. THE INFORMATION PROVIDED INDICATES THAT ALL ADVERSE EVENTS IMPROVED DURING THE 24-HOUR POST PROCEDURE HOSPITAL STAY. THE COOK QUICK-CORE ULTRASOUND BIOPSY NEEDLES ARE CURRENTLY OBSOLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685176 QUICK-CORE ULTRASOUND BIOPSY NEEDLE FCG COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GF-UCT2000-OL5, OLYMPUS ENDOSCOPE