BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE HEMOSTASIS CLIP

    MDR report key: 2885258 · Received December 18, 2012

    Report

    Report Number
    1037905-2012-00695
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K121505
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. PRIOR TO DISTRIBUTION, ALL DISPOSABLE HEMOSTASIS CLIPS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: 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 AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE AFTER REMOVAL OF A POLYP, FOUR (4) COOK DISPOSABLE HEMOSTASIS CLIPS WERE SUCCESSFULLY PLACED. AT THIS TIME THEY NOTICED A SECTION OF THE LESION WAS OPEN SO THE PHYSICIAN PLACED A FIFTH COOK DISPOSABLE HEMOSTASIS CLIP. DURING PLACEMENT OF THE FIFTH CLIP, IT WAS NOTED THAT THE FIRST FOUR WERE SLIDING OFF THE CLIPPING SITE. DURING PLACEMENT OF A SIXTH COOK DISPOSABLE HEMOSTASIS CLIP, ALL OF THE PREVIOUSLY PLACED FIVE (5) CLIPS HAD FALLEN OFF THE CLIPPING SITE. THE SIXTH CLIP DID NOT STAY ON THE CLIPPING SITE AS WELL. ALL SIX CLIPS WERE IN THE OPEN POSITION WHEN THEY FELL OFF THE CLIPPING SITE. SEE MDRS 1037905-2012-00695, 00696, 00697, 00698, 00699 AND 006700. THE INITIAL REPORTER STATED THAT THE PLACEMENT TECHNIQUE USED BY THE PHYSICIAN FOR ALL SIX COOK DISPOSABLE HEMOSTASIS CLIPS WAS APPLIED PROPERLY. IN AN EFFORT TO FINISH THE PROCEDURE, THE PHYSICIAN USED A BOSTON-SCIENTIFIC RESOLUTION CLIP, BUT THIS CLIP DID NOT STAY ATTACHED TO THE CLIPPING SITE. THE PHYSICIAN ENDED THE PROCEDURE AND PLACED THE PATIENT UNDER WATCH, STATING THAT THE BLEEDING SHOULD STOP SPONTANEOUSLY. ALL OF THE CLIPS WERE LEFT TO PASS NATURALLY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT IMMEDIATELY REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE, BUT IT IS UNKNOWN IF ANY WERE REQUIRED IN THE LONG TERM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE HEMOSTASIS CLIP LIGATOR, HEMORRHOIDAL MND WILSON-COOK MEDICAL INC W3208033

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization BOSTON SCIENTIFIC REVOLUTION CLIP| OLYMPUS DUODENOSCOPE (UNKNOWN TYPE)