BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 4121350 · Received September 19, 2014

    Report

    Report Number
    1037905-2014-00363
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 20, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K944220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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 CONCLUSIONS: 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. PRIOR TO DISTRIBUTION, ALL 6 SHOOTER MULTI-BAND LIGATORS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED REMOTE. 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.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR WAS USED. AFTER SUCCESSFUL BAND LIGATION OF THE ESOPHAGEAL VARIX, THE PSEUDO-POLYP FELL OFF AND CREATED AN ULCERATIVE SITE. THIS IS NORMAL PER THE DOCTOR'S DESCRIPTION. THE PROCEDURE WAS COMPLETED WITH THE DEVICE IN QUESTION. HOWEVER, AFTER AN [UNK] PERIOD OF TIME, THE PATIENT NEARLY EXSANGUINATED FROM THE SITE. THE DOCTOR FURTHER WENT ON TO MENTION THAT THIS WAS DUE TO PATIENT ANATOMY AND NOT A DEVICE FAILURE. THE DOCTOR SAID THAT THESE HAPPEN RARELY AND HE BELIEVES IT IS NOT SOLELY A DEVICE RELATED ISSUE. THE PATIENT IS DOING BETTER NOW. NO INTERVENTIONS WERE PERFORMED DURING THE INITIAL PROCEDURE. OTHER THAN THE DEPLOYED BANDS, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE [POST PROCEDURE] BUT IT IS UNK WHAT TYPE OF ADDITIONAL PROCEDURES WERE PERFORMED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE BUT IS RECOVERING. MULTIPLE ATTEMPTS TO COLLECT ADDITIONAL INFO REGARDING THE PATIENT'S CURRENT CONDITION WERE MADE BUT WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583664 6 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OLYMPUS ENDOSCOPE (UNK MODEL NO.)