BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAUTERY FORCEPS WITH FOOTSWITCH

    MDR report key: 3244195 · Received July 18, 2013

    Report

    Report Number
    1223422-2013-00024
    Event Type
    Other
    Date Received
    July 18, 2013
    Date of Event
    June 6, 2013
    Report Date
    July 15, 2013
    Manufacturer
    MICROLINE SURGICAL
    Product Code
    GEI
    PMA / PMN Number
    K000250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENTCEPS USED DURING SURGERY WERE DISCARDED AT THE HOSP; THEREFORE, NO INVESTIGATION COULD BE CONDUCTED ON THE DEVICES USED. ELEVEN STERILE UNOPENED ENTCEPS HAVING THE SAME LOT NUMBER WERE RETURNED. ONE OF THE ELEVEN STERILE ENTCEPS HAVING THE SAME LOT NUMBER RETURNED WAS OPENED, PLUGGED INTO A TEST FOOTSWITCH AND TEST UNIVERSAL POWER SUPPLY IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE WAS TESTED WITH A WET GAUZE. THE RETURNED DEVICE WORKED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE AND NO ISSUES WERE NOTED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO MFG ISSUES. NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED FOR THIS LOT NUMBER. DUE TO NUMBER OF DAYS BETWEEN THE INITIAL SURGERY DATE ((B)(6) 2013) AND THEN THE 1ST DATE ((B)(6) 2013) AND 2ND DATE ((B)(6) 2013) POST-OP BLEEDING, THE CAUSE OF THE BLEEDING IS UNRELATED TO THE MEDICAL DEVICES. THIS MDR IS CONNECTED TO 1223422-2013-00023 AND 1223422-2013-00025.

    Description of Event or Problem · 1

    THE POST-OPERATION BLEED WAS (B)(6) ON THE PT'S RIGHT SIDE. RESULT: GARGLE WITH ICE WATER, NEEDED ELECTRO-SURGICAL PENCIL TO CREATE HEMOSTASIS THEN WENT BACK TO ER ON (B)(6) FOR THE SECOND POST-OPERATION BLEED ON THE "OTHER SIDE". NO ADDITIONAL PT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335352 CAUTERY FORCEPS WITH FOOTSWITCH ENTCEPS GEI MICROLINE SURGICAL 110-005D 53730

    Patients

    Seq Age Sex Outcome Treatment
    1