BEUDAMED
    FDA Adverse Event Death Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 15473672 · Received September 23, 2022

    Report

    Report Number
    1037905-2022-00526
    Event Type
    Death
    Date Received
    September 23, 2022
    Date of Event
    May 22, 2021
    Report Date
    September 22, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 AND NO DEVICE FAILURE COULD BE IDENTIFIED. THE POTENTIAL COMPLICATIONS IN THE INSTRUCTIONS FOR USE STATE: "THOSE ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY INCLUDE, BUT ARE NOT LIMITED TO: HEMORRHAGE." IN AN EVENT OF BLEEDING, THE INSTRUCTIONS FOR USE ADVISE THE USER: ¿REPEAT LIGATION PROCESS AS NEEDED. NOTE: MORE THAN ONE LIGATION BAND FOR EACH VARIX MAY BE REQUIRED TO CONTROL ACUTE BLEEDING. IF MORE BANDS ARE REQUIRED, REMOVE ENDOSCOPE AND ATTACH A NEW DEVICE. NOTE: AN AVERAGE OF 3 TO 4 LIGATION SESSIONS MAY BE REQUIRED TO OBLITERATE VARICES.¿ PRIOR TO DISTRIBUTION, ALL 6 SHOOTER SAEED MULTI-BAND LIGATORS ARE 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 RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE. HUANG, Y. (2021). IMPACT OF PORTAL VEIN THROMBOSIS ON ENDOSCOPIC VARICEAL BAND LIGATION IN LIVER CIRRHOSIS. JOURNAL OF HEALTHCARE ENGINEERING, 2021, 1¿6. HTTPS://DOI.ORG/10.1155/2021/9929333.

    Description of Event or Problem · 0

    COOK BECAME AWARE OF THE ATTACHED CLINICAL LITERATURE ARTICLE INVOLVING COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. SEE RELEVANT EXCERPTS: "WE ESTABLISHED RETROSPECTIVE INVESTIGATION ON 144 CONSECUTIVE CIRRHOTIC PATIENTS RECEIVING ENDOSCOPIC VARICEAL BAND LIGATION (EVL) IN FIRST TIME IN GASTROINTESTINAL ENDOSCOPY CENTER OF THE FIRST AFFILIATED HOSPITAL, COLLEGE OF MEDICINE, ZHEJIANG UNIVERSITY, FROM JANUARY 2014 TO DECEMBER 2017. THIS STUDY WAS APPROVED BY THE FIRST AFFILIATED HOSPITAL ETHICS COMMITTEE OF ZHEJIANG UNIVERSITY COLLEGE OF MEDICINE. "COMMON POSTOPERATIVE COMPLICATIONS INCLUDE ULCER-RELATED BLEEDING AFTER THE LIGATION (WHICH CAN CAUSE FATAL HEMORRHAGE), FEVER, AND RETROSTERNAL PAIN. "THE IMPLEMENTATION AND USED EQUIPMENT OF ENDOSCOPIC VARICEAL BAND LIGATION (EVL). ALL THE ENDOSCOPIC ESOPHAGEAL VARICES LIGATION (EVL) WAS OPERATED BY SENIOR GASTROENTEROLOGIST. THREE BLEEDING-RELATED DEATHS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553685 6 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR MND WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death OLYMPUS SCOPE