BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIZACT

    MDR report key: 19217760 · Received April 30, 2024

    Report

    Report Number
    1717344-2024-01088
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    April 5, 2024
    Report Date
    April 30, 2024
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: BZ4212, OPEN SEALER/DIV BZ4212 BIZACT 5MM-12CM (LOT#40240250X). H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE EVALUATION FOUND NO POTENTIALLY CONTRIBUTING FACTORS, AND THE SAMPLE MET ALL RELATED SPECIFICATIONS. IT WAS REPORTED THAT THE JAWS WERE DIFFICULT TO OPEN. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE IDENTIFIED BECAUSE NO RELATED PROBLEM WAS DETECTED WITH THE DEVICE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. 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. 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 TONSILLECTOMY PROCEDURE, THE DEVICE WORKED PERFECTLY, HOWEVER, THE JAWS OF THE DEVICE WERE NOT O PENING/LOSING AS SMOOTHLY AS POSSIBLE. ANOTHER DEVICE ALSO WORKED PERFECTLY, BUT THE JAWS WERE ALSO NOT OPENING/LOSING AS SMOOTHLY AS POSSIBLE. THE DEVICES WERE APPLIED TO TONSILS TISSUE AT THE TIME, AND THE MALFUNCTION HAPPENED THROUGHOUT THE DISSECTION PROCESS. THE DEVICES WERE CLEANED WHENEVER NEEDED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160438 BIZACT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER BZ4212 40110081X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose