BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLIP

    MDR report key: 9748795 · Received February 25, 2020

    Report

    Report Number
    8010047-2020-01486
    Event Type
    Injury
    Date Received
    February 25, 2020
    Report Date
    February 25, 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 BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC). OMSC COULD NOT REVIEW THE SERVICE AND MANUFACTURING RECORD BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED FROM THE FACILITY. THE MALFUNCTION OF THE SUBJECT DEVICE CONCERNING THIS CASE HAS NOT BEEN REPORTED. THE EXACT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLE "COMPARISON BETWEEN ENDOSCOPIC AND LAPAROSCOPIC REMOVAL OF GASTRIC SUBMUCOSAL TUMOR". THE LITERATURE REPORTED THE RESULT OF 73 CASES OF THE FOLLOWING PROCEDURES USING AN OLYMPUS MODEL SINGLE-USE RELOADABLE CLIP (HX-610-135). -ENDOSCOPIC RESECTION (ER) PROCEDURES (ENDOSCOPIC SUBMUCOSAL DISSECTION [ESD], ENDOSCOPIC MUSCULARIS DISSECTION [EMD], AND ENDOSCOPIC FULL-THICKNESS RESECTION [EFTR]). -LAPAROSCOPIC RESECTIONS (LR) PROCEDURES (LAPAROSCOPIC ENDOSCOPIC COOPERATIVE SURGERY [LECS] AND LAPAROSCOPIC WEDGE RESECTION). IN THE SUBJECT PROCEDURES, 3 CASES OF CONVERSION TO LAPAROSCOPIC SURGERY AND 2 CASES OF POSTOPERATIVE BLEEDING REPORTEDLY OCCURRED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICES AND THE OBSERVED REPORTED ADVERSE EVENTS COULD NOT BE DETERMINED. ACCORDING TO THE NUMBER OF ADVERSE EVENTS AND THE NUMBER OF OLYMPUS DEVICES INVOLVED IN THE EVENTS, OMSC IS SUBMITTING 5 MEDICAL DEVICE REPORTS. THIS IS THE 2ND OF 2 REPORTS FOR POSTOPERATIVE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214479 CLIP CLIP PKL OLYMPUS MEDICAL SYSTEMS CORP. HX-610-135 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1