BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37 CM

    MDR report key: 3002671 · Received February 13, 2013

    Report

    Report Number
    3006451981-2013-00039
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    November 29, 2012
    Report Date
    February 17, 2018
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORTER WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED AND EVALUATED. EVALUATION SUMMARY: ONE LS1037 LIGASURE DEVICE WAS RECEIVED FOR EVALUATION. THIS DEVICE HAD BEEN USED IN THE TREATMENT OR DIAGNOSIS OF A PATIENT. A REVIEW OF THE LOT NUMBER REPORTED INDICATES THAT THE PRODUCT WAS WITHIN THE ASSIGNED EXPIRATION DATE AT THE TIME OF THE REPORTED INCIDENT. THE RETURNED PRODUCT MET SPECIFICATION AS RECEIVED. VISUAL INSPECTION FOUND NO DEFECTS. THE DEVICE WAS RETURNED CLEAN WITH NO TISSUE IN THE JAWS. THE INVESTIGATION OF THE RETURNED EQUIPMENT DID NOT IDENTIFY ANYTHING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE JAWS OPENED AND CLOSED NORMALLY USING THE HANDLE. THE DEVICE WAS ACTIVATED MULTIPLE TIMES ON A SALINE SOAKED TOWEL WITH ACCEPTABLE RESULTS AND VISUAL SEAL EFFECTS WERE OBSERVED. ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY AND END TONES WERE HEARD EACH TIME. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE JAWS COULD NOT OPEN AFTER SEALING. IT IS UNK HOW THE JAWS WERE REMOVED. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63716 LIGASURE ATLAS HANDSWITCHING 37 CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S2B0015X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK