BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSTAT II ELECTROSURGICAL GENERATOR

    MDR report key: 67118 · Received February 5, 1997

    Report

    Report Number
    1221941-1997-00002
    Event Type
    Injury
    Date Received
    February 5, 1997
    Report Date
    January 9, 1997
    Manufacturer
    MICROVASIVE ENDOSCOPY DIB OF BOSTON SICIENTIFIC CORP.
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AT THE USER FACILITY. THE ENGINEERING EVALUATION INDICATED THE OUTPUT IN THE BLEND MODE EXCEEDED THE MAXIMUM SPECIFICATION, IN ONE OF THE FOUR RANGES TESTED, BY 1.1 VOLTS. THE MAXIMUM ALLOWED IS 155.6 VOLTS AND THE DEVICE'S ACTUAL READING WAS 156.5 VOLTS. ALL OTHER READINS WERE WITHIN SPECIFICATION. ACCORDING TO THE MFR, AN ADDITIONAL 1.1 VOLTS SHOULD NOT CAUSE A NOTICEABLE DIFFERENCE IN RESULTS. IT WAS ALSO INDICATED THE INITIAL PROCEDURE WAS PERFORMED WITHOUT INCIDENT. THEREFORE, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THE RESULTANT PERFORATION. HOWEVER, THE PHYSICIAN STATED SESSILE POLYPS HAVE A POTENTIAL COMPLICATION OF PERFORATION. H6 - 400 (OTHER - OUTPUT BLEND). F11 - DATE MFR INITIALLY FORWARDED REPORT TO FDA.

    Description of Event or Problem · 1

    CO WAS INFORMED OF AN INCIDENT THAT OCCURRED INVOLVING GENERATOR. A SESSILE POLYP WAS REMOVED FROM THE CECUM WITHOUT INCIDENT DURING A SUCCESSFUL POLYPECTOMY PROCEDURE. APPROX 10-12 HOURS POST PROCEDURE, THE PT PRESENTED WITH ABDOMINAL PAIN. SUBSEQUENTLY, A PERFORATION WAS DIAGNOSED. SUCCESSFUL SURGICAL REPAIR OF THE PERFORATION FOLLOWED. THE PT'S CONDITION IS GOOD. IT WAS INDICATED THE CASE WAS PERFORMED WITHOUT INCIDENT. THEREFORE, WITHOUT EVALUATING THE DEVICE, CO IS UNABLE TO DETERMINE THE CAUSE FOR THIS EVENT. SHOULD FURTHER DETAILS BECOME AVAILABLE, A SUPPLEMENT WILL BE FORWARDED. NO PT INFO IA AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTAT II ELECTROSURGICAL GENERATOR ELELCTROSURGICAL GENERATOR KNS MICROVASIVE ENDOSCOPY DIB OF BOSTON SICIENTIFIC CORP. NA 687

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention