BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLIP

    MDR report key: 10606051 · Received September 30, 2020

    Report

    Report Number
    8010047-2020-07023
    Event Type
    Injury
    Date Received
    September 30, 2020
    Report Date
    September 30, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    PKL
    PMA / PMN Number
    K183590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE SERIAL NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES THAT PASSED THE INSPECTION. IN THE LITERATURE, THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

    Description of Event or Problem · 1

    ON (B)(6) 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED " USEFULNESS OF WOUND PLICATION USING SURECLIP IN ENDOSCOPIC NIPPLE RESECTION". IN THE LITERATURE, IT WAS REPORTED THAT COMPLICATIONS OF INTRAOPERATIVE BLEEDING, POSTOPERATIVE BLEEDING, PERFORATION, PANCREATITIS, AND BILIARY ATRESIA WERE OCCURRED DURING THE ENDOSCOPIC PAPILLOTOMY USING THE SUBJECT DEVICE. THIS STUDY WAS CONDUCTED THE ENDOSCOPIC PAPILLOTOMY FOR DUODENAL PAPILLA LESION ON 36 PATIENTS BETWEEN OCTOBER 2009, AND SEPTEMBER 2019. THE SUBJECT DEVICE OR THE COMPETITOR DEVICE WERE USED WITH THE WOUND PLICATION AS A BLEEDING PREVENTION METHOD IN THE ENDOSCOPIC PAPILLOTOMY. THE REPORTED PERFORATION, PANCREATITIS, AND BILIARY ATRESIA WERE NOT ABLE TO IDENTIFY WITH RELATION TO THE SUBJECT DEVICE IT WAS NOT REPORTED THAT A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE OBSERVED ADVERSE EVENTS. WHEREAS, OMSC ASSUME THAT THE COMPLICATION OF THE CONVERT TO OPEN SURGERY WAS RELATED TO THE SUBJECT DEVICE DUE TO INTRAOPERATIVE BLEEDING REQUIRED FOR ARTERIAL OCCLUSION AND BLOOD TRANSFUSION. HOWEVER, IT WAS NOT REPORTED THAT A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THIS ADVERSE EVENT. BASED ON THE AVAILABLE INFORMATION, DETAILED INFORMATION OF THE SUBJECT DEVICE WAS NOT PROVIDED. THEREFORE, OMSC WILL SUBMIT ONE MEDICAL DEVICE REPORT (MDR) FOR THE INTRAOPERATIVE BLEEDING OF THE CONVERT TO OPEN SURGERY OF THE SUBJECT DEVICE. THIS IS THE REPORT REGARDING THE INTRAOPERATIVE BLEEDING OF THE CONVERT TO OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075008 CLIP CLIP PKL OLYMPUS MEDICAL SYSTEMS CORP. HX-610-090

    Patients

    Seq Age Sex Outcome Treatment
    1 Other