BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 9307091 · Received November 11, 2019

    Report

    Report Number
    3006451981-2019-00227
    Event Type
    Malfunction
    Date Received
    November 11, 2019
    Date of Event
    October 25, 2019
    Report Date
    December 1, 2019
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING HEMORRHOIDECTOMY, SEALING OF THE DEVICE WAS CONTINUED FOR SEVERAL SECOND AND DID NOT STOP UNTIL A REGRASP ALARM. THE TISSUE SEEMS TO BE OVER SEAL, CAN SEE SOME LATERAL HEAT DAMAGE TO ADJACENT TISSUE. THE PATIENT GOT AN EXTRA PAIN OR EXTRA RECOVERY TIME DUE TO TISSUE DAME BUT THERE WAS NO TISSUE LOSS. THERE WAS ALSO NO INTERVENTION DONE WITH REGARDS THE TISSUE DAMAGE. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. THIS REPORT IS ASSOCIATED TO A SIMILAR PRODUCT SOLD IN THE US WITH 510(K) NUMBER K102470. EVALUATION SUMMARY: ONE DEVICE WAS RECEIVED FOR EVALUATION. THE DEVICE WAS PLUGGED INTO A DEVICE, AND GENERATOR WAS SUCCESSFULLY RECOGNIZED BE EACH GENERATOR. THE DEVICE WAS ACTIVATED ON A SALINE SOAKED TOWEL WITH SATISFACTORY RESULTS. ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY AND END TONES WERE HEARD INDICATING COMPLETED ACTIVATION CYCLES. NO SELF-ACTIVATION WAS OBSERVED. 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

    ACCORDING TO THE REPORTER, DURING HEMORRHOIDECTOMY, SEALING OF THE DEVICE WAS CONTINUED FOR SEVERAL SECOND AND DID NOT STOP UNTIL A REGRASP ALARM. THE TISSUE SEEMS TO BE OVER SEAL, CAN SEE SOME LATERAL HEAT DAMAGE TO ADJACENT TISSUE. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098769 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MEDICAL PRODUCTS LF1212 S9EH720X

    Patients

    Seq Age Sex Outcome Treatment
    1