BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIZACT

    MDR report key: 20359407 · Received October 3, 2024

    Report

    Report Number
    1717344-2024-01918
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    September 18, 2024
    Report Date
    December 19, 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

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION FOUND THE DEVICE'S KNIFE BLADE AND JAW WERE STUCK ON ESCHAR BUILDUP. FUNCTIONAL TESTING NOTED THAT THE KNIFE BLADE WAS STUCK ON ESCHAR BUILDUP, WHICH PREVENTED THE KNIFE FROM ADVANCING FORWARD OR RETRACTING BACK TO ITS HOME POSITION. THIS ALSO HINDERED THE JAW'S FUNCTION. THE KNIFE TRIGGER WAS PRESSED TO RELEASE THE KNIFE BLADE FROM THE ESCHAR BUILD UP. THE KNIFE BLADE WAS ABLE TO ADVANCE AND RETRACTED PROPERLY AFTER IT WAS CLEARED FROM THE BUILDUP. MORE FREQUENT CLEANING OF THE JAWS COULD HAVE PREVENTED BUILD UP OF ESCHAR. THE DEVICE'S JAW OPENING AND CLOSING MECHANISM WAS FUNCTIONING PROPERLY. THE WELD INTEGRITY OF THE DEVICE WAS INSPECTED AND WAS FOUND TO BE WITHIN SPECIFICATION. THE KNIFE CUT OF THE DEVICE WAS TESTED ON A SILICONE TEST STRIP WITH ACCEPTABLE RESULTS. THE HEEL GAP OF THE DEVICE WAS MEASURED AND IT WAS FOUND TO BE WITHIN SPECIFICATION. THE DEVICE WAS DETECTED AND ACTIVATED MULTIPLE TIMES ON A SALINE SOAKED GAUZE PAD WITH SATISFACTORY RESULTS. ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY AND END TONES WERE HEARD INDICATING COMPLETED ACTIVATION CYCLES. NO ELECTRICAL OR WIRING ISSUES WERE FOUND. IT WAS REPORTED THAT DEVICE WAS DIFFICULT/IMPOSSIBLE TO CLOSE AND THE JAWS WERE DIFFICULT TO OPEN. THE REPORTED ISSUES WERE 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: KEEP THE INSTRUMENT JAWS CLEAN. BUILD UP OF ESCHAR MAY REDUCE SEALING OR CUTTING EFFECTIVENESS. WIPE JAW SURFACES AND EDGES WITH A WET GAUZE PAD AS NEEDED. 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.

    Additional Manufacturer Narrative · 0

    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 PROCEDURE, THE JAW WAS STICKING AND HAD DIFFICULTY OPENING AND CLOSING. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING PROCEDURE, IN TONSILS, THE JAW WAS STICKING AND HAD DIFFICULTY OPENING AND CLOSING. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091866 BIZACT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER BZ4212 40530116X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown