BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLIP

    MDR report key: 17188024 · Received June 22, 2023

    Report

    Report Number
    9614641-2023-00894
    Event Type
    Injury
    Date Received
    June 22, 2023
    Date of Event
    April 26, 2023
    Report Date
    June 22, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    PKL
    UDI-DI
    04953170200311
    PMA / PMN Number
    K183590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE LITERATURE DESCRIBED "EZ CLIP", OLYMPUS SELECTED "HX-610-135" AS A REPRESENTATIVE PRODUCT. THIS DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "PS-10 EVALUATION OF THE USEFULNESS OF PROPHYLACTIC CLIPPING WITH SURECLIP FOR WOUND BLEEDING AFTER ENDOSCOPIC PAPILLECTOMY". COMPLICATIONS INCLUDING POSTOPERATIVE WOUND BLEEDING ARE FREQUENTLY OBSERVED IN ENDOSCOPIC PAPILLECTOMY (EP). WE HAVE LONG USED A CLIP TO SUTURE THE WOUND TO PREVENT WOUND BLEEDING. RECENTLY, WE HAVE BEEN USING THE SURE CLIP (MICRO-TECH), WHICH IS EASY TO OPERATE EVEN WITH A DUODENOSCOPE. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE EFFICACY OF SURE CLIP PLACEMENT FOR POST-EP WOUND BLEEDING. TYPE OF ADVERSE EVENT/NUMBER OF PATIENTS: BLEEDING - 39.2%; PANCREATITIS - 8.7%; CHOLANGITIS - 0.5%; PERFORATION - 3.3%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822677 CLIP CLIP PKL AOMORI OLYMPUS CO., LTD. HX-610-135 UNKNOWN(LITERATURE) 04953170200311

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other