BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSATION JUMBO OVAL (SGL)

    MDR report key: 1060092 · Received June 4, 2008

    Report

    Report Number
    3005099803-2008-00597
    Event Type
    Injury
    Date Received
    June 4, 2008
    Date of Event
    February 19, 2008
    Report Date
    May 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNS
    PMA / PMN Number
    K885005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT INVOLVED IS NOT AVAILABLE FOR ANALYSIS. PRODUCT ANALYSIS CAN NOT BE PERFORMED. THE CUSTOMER DID NOT REPORT A LOT NUMBER. A SHIP HISTORY PERFORMED FOR UNITS SHIPPED TO THIS CUSTOMER FOUND TWO LOTS WERE SOLD TO THIS CUSTOMER IN THE 6 MONTHS BEFORE THE EVENT DATE. DHR WAS REVIEWED FOR BOTH POTENTIAL LOTS AND DEVIATIONS WERE NOT FOUND. ALSO LABELING REVIEW WAS PERFORMED FOR BOTH LOTS AND ALL INFO WAS WITHIN SPEC. THERE IS NO UNFAVORABLE TREND AT THIS TIME FOR THIS KIND OF COMPLAINT. IT IS IMPORTANT TO MENTION THAT ACCORDING TO DFU: ..."THE SNARE DELIVERS A MONOPOLAR ELECTRICAL CURRENT TO CUT AND CAUTERIZE TISSUE WITH THE LOOP... POTENTIAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO : - PERFORATION - FULGURATION - IMMEDIATE OR DELAYED HEMORRHAGES - TRANSMURAL BURNS, CHARACTERIZED BY ABDOMINAL PAIN, FEVER, AND TRANSIENT ILLEUS... WARNING: BECAUSE THE ELECTROSURGICAL EFFECT IS GREATLY INFLUENCED BY THE SIZE AND CONFIGURATION OF THE ACTIVE ELECTRODE, IT IS IMPOSSIBLE TO DETERMINE THE EXACT EFFECT ACHIEVED IN A GIVEN CONTROL SETTING. IT IS VERY IMPORTANT THAT IF THE PROPER SETTING OF THE GENERATOR IS NOT KNOWN, ONE SHOULD SET THE UNIT AT A POWER SETTING LOWER THAN THE RECOMMENDED RANGE AND CAUTIOUSLY INCREASE THE POWER UNTIL THE DESIRED EFFECT IS ACHIEVED..." THE COMPLAINT IS NOT CONFIRMED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLONOSCOPY AND POLYPECTOMY PROCEDURE A BOWEL PERFORATION OCCURRED. THE COLONOSCOPY AND POLYPECTOMY WERE REPORTED TO INVOLVE PERFORATION OF THE PT'S BOWEL AND PERITONITIS. SURGICAL REPAIR OF THE PERFORATION WAS PERFORMED. THE PT'S STATUS FOLLOWING THE SURGICAL REPAIR IS UNK. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSATION JUMBO OVAL (SGL) KNS KNS BOSTON SCIENTIFIC M00562650 *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| R