BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIZACT

    MDR report key: 19229278 · Received May 2, 2024

    Report

    Report Number
    1717344-2024-01105
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    April 4, 2024
    Report Date
    May 2, 2024
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: FORCETRIAD FORCE TRIAD ENERGY PLATFORM (SERIAL#: T1D22182EX) 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. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE INSULATION AT THE TIP OF THE JAWS HAD CHIPPED OFF AND PIECE OF INSULATION NOT FOUND/NOT RETURNED. ANALYSIS FOUND THAT THE INSULATION AT THE TIP OF THE JAW WAS BROKEN, CONSISTENT WITH THE FAILURE MODE CAUSE BY OFF LABEL USE WITH EXCESSIVE TORQE APPLIED ON THE JAWS, USER INADVERTENTLY CLOSING JAWS ON A HARD OBJECT, OR DROPPING OF THE DEVICE. IT WAS REPORTED THAT THERE WAS DEVICE RELATED BURN. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: DO NOT ATTEMPT TO SEAL OR CUT OVER CLIPS OR STAPLES AS INCOMPLETE SEALS OR DAMAGE TO THE INSTRUMENT CAN OCCUR. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING A THYROID SURGERY, THERE WAS A PROBLEM WITH THE EQUIPMENT, BIZACT CLAMP AND A NON-MEDTRONIC BIPOLAR CLAMP. THE PATIENT HAD BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841710 BIZACT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER BZ4212 33140109X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE NOTE ON H11