BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE ELECTROSURGICAL SNARE

    MDR report key: 12465851 · Received September 14, 2021

    Report

    Report Number
    8010047-2021-11679
    Event Type
    Injury
    Date Received
    September 14, 2021
    Report Date
    September 14, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    K955650
    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

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "AN EVALUATION OF RESECTABILITY AMONG ENDOSCOPIC TREATMENT METHODS FOR RECTAL NEUROENDOCRINE TUMORS <10 MM". THE LITERATURE REPORTED THE RESULT OF 61 PATIENTS WITH RECTAL NEUROENDOCRINE TUMORS <10 MM WHO UNDERWENT ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE USING OLYMPUS ELECTROSURGICAL SNARE OR UNDERWENT ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE USING NON OLYMPUS FLUSH ELECTROSURGICAL KNIFE FROM MAY 2003 TO NOVEMBER 2019. IN THE LITERATURE, IT WAS REPORTED COMPLICATION AS FOLLOWS; POST-OPERATIVE BLEEDING (2 CASES). INTRAOPERATIVE PERFORATION (EMR: 1CASE, ESD: 1CASE). THERE ARE NOT MENTIONED THAT THESE COMPLICATIONS WERE RELATED TO THE SUBJECT DEVICE IN QUESTION. BASED ON THE AVAILABLE INFORMATION, SPECIFIC INFORMATION ON THE SUBJECT DEVICE AND THE PATIENTS WERE NOT PROVIDED. THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION. HOWEVER, OMSC ASSUMES THAT "INTRAOPERATIVE PERFORATION (EMR: 1CASE)" MIGHT BE RELATED TO THE SUBJECT DEVICE, AND THE SUBJECT DEVICE MIGHT BE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. IN ADDITION, "INTRAOPERATIVE PERFORATION (ESD: 1 CASE)" OCCURRED DURING A PROCEDURE USING NON OLYMPUS FLUSH ELECTROSURGICAL AND IS NOT RELATED TO THE SUBJECT DEVICE. THEREFORE, OMSC DETERMINED THAT THE "INTRAOPERATIVE PERFORATION (EMR: 1CASE)" WAS ADVERSE EVENT TO SUBMIT. OMSC WILL SUBMIT A MEDICAL DEVICE REPORT (MDR) DEPENDING ON THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367027 DISPOSABLE ELECTROSURGICAL SNARE DISPOSABLE ELECTROSURGICAL SNARE FDS OLYMPUS MEDICAL SYSTEMS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other