BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIZACT

    MDR report key: 7383042 · Received March 29, 2018

    Report

    Report Number
    1717344-2018-00440
    Event Type
    Malfunction
    Date Received
    March 29, 2018
    Date of Event
    March 15, 2018
    Report Date
    May 21, 2018
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 K171066. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ONE 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 DID NOT MEET SPECIFICATION AS RECEIVED. VISUAL INSPECTION FOUND THE A MODEL PLASTIC COATING CHIPPED AND BROKE AT THE BASE OF THE JAW. THE CHIPPED PIECE WAS ALSO RECEIVED. THE DEVICE WAS USED WITH A LOT OF ESCHAR ON THE JAWS. THE REPORTED CONDITION WAS CONFIRMED. DURING VISUAL INSPECTION, IT WAS NOTED THAT PART OF THE OVER MOLD WAS MISSING FROM ONE OF THE JAWS, THE JAW WITH THE DOTS AND ON THE INSIDE CURVE OF THE JAWS. THE MISSING PIECE WAS ISOLATED IN A BAG WITH THE REST OF THE DEVICE. IN AN ATTEMPT TO REPLICATE THE CONDITION, THE ENGINEERING TEAM ATTEMPTED TO DAMAGE SEVERAL PRODUCTION DEVICES WITH A HEMOSTAT AND OTHER INSTRUMENTS, TO SEE IF THE SAME SECTION OF A MODEL WOULD BREAK OFF. THE ONLY WAY ENGINEERING WAS ABLE TO GET THIS PARTICULAR SECTION OF A MODEL TO BREAK OFF WAS BY GRABBING THIS SECTION OF THE A MODEL WITH A HEMOSTAT AND RIPPING IT OFF. IT IS BELIEVED, THAT AS THIS PIECE WAS FOUND, THAT IT IS LIKELY THAT A HEMOSTAT OR SIMILAR INSTRUMENT WAS USED TO GRASP THIS SECTION OF THE JAW AND BROKE THE PIECE OF A MODEL OFF THE INSTRUMENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING USE, THE UNIT HAD AN INSULATION ISSUE. ACCORDINGLY, IT FELL APART. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING USE, THE UNIT HAD AN INSULATION ISSUE. THE INSULATION ON THE TIP ONE PART FELL APART.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING USE, THE UNIT HAD AN INSULATION ISSUE. THE INSULATION ON THE TIP ONE PART FELL APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223888 BIZACT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER BZ4212 72200221X

    Patients

    Seq Age Sex Outcome Treatment
    1