BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EB217, VOYANT MARYLAND FUSION 23CM, 6/BX

    MDR report key: 17608362 · Received August 23, 2023

    Report

    Report Number
    2027111-2023-00571
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    August 2, 2023
    Report Date
    November 30, 2023
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GEI
    UDI-DI
    00607915139377
    PMA / PMN Number
    K200598
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE IF THE REPORTED EVENT WAS CAUSED BY A MANUFACTURING NON-CONFORMANCE OR CIRCUMSTANTIAL FACTORS AT THE TIME OF USE. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 0

    NO PRODUCT IS BEING RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: GYN EVENT DESCRIPTION: EVENT 1 OF 3: 2023-002227 [MFR #2027111-2023-00571] EVENT 2 OF 3: 2023-002271 [MFR #2027111-2023-00573] EVENT 3 OF 3: 2023-002281 [MFR #2027111-2023-00574] MODEL IS EB15 OR EA020. IT IS UNKNOWN IF A PATIENT INJURY OR ILLNESS OCCURRED. USED ANOTHER HANDPIECE BUT SAME PROBLEM - NO SEALING INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 4AUG23: LOT NO: 1484419, SURGERY: GYN I WILL CHECK UP MORE SPECIFIC. NO PATIENT WAS HURT. THE HOSPITAL HAS KEPT THE HANDLE USED IN THE SURGERY AT THE MEDICO DEPARTMENT. I CHECKED THE HANDLE AND GENERATOR, THE NURSE, MEDICO TECHNICIAN AND I DID ALSO TEST THE EB215 HANDLE ON A WET NAPKIN. BOTH HANDLES WERE WORKING FINE ¿ NO PROBLEM AT ALL. WE DID CALL THE DOCTOR WHO HAVE HAD THE ISSUES, TRYING TO TALK TO HIM. THE DOCTOR WAS GONE HOME DUE TO HIS NIGHTSHIFT ENDING. INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 7AUG23: I HAVE BEEN IN CONTACT WHIT THE DOCTOR [NAME REDACTED] THIS MORNING, HE IS THE ONE USING THE HANDLES. HE INFORMS ME THAT BOTH HANDLES DIDN´T ACTIVATE WHEN HE WAS USING THE ACTIVATE BUTTON. BUT ACTIVATION DID START WHEN HE WAS USING THE KNIFE. I INFORMED HIM THAT WE HAVE TESTED THE 2 HANDLES USED AT THE DEPARTMENT LAST FRIDAY AND WE COULD NOT FIND ANY ISSUES WITH THE HANDLES. INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA PHONE 8AUG23: THE INCIDENT OCCURRED WITH (B)(4) UNITS OF EB217 LOT 1484419. ONE EVENT OCCURRED ON 29JULY23 AND 2 EVENTS OCCURRED ON 02AUG23. THE (B)(4) UNITS EXPERIENCED THE SAME PROBLEM, AS FAR AS I KNOW. THE LOT NUMBER OF THE EVENT UNITS IS 1484419. NO PATIENT INJURY OCCURRED. THERE WERE NO CONSEQUENCES ON THE PATIENT. NAME OF THE PROCEDURE IS UNKNOWN. TYPE OF TISSUE BEING GRASPED WHEN THE EVENT HAPPENED IS UNKNOWN. THE EXPERIENCE WAS OBSERVED IMMEDIATELY AFTER USING THE DEVICE. IT IS UNKNOWN IF THE READY MESSAGE WAS DISPLAYED ON THE SCREEN, OR IF THEY RECEIVED ANY ALARMS. THE ACTIVATION TONE WAS HEARD BUT ONLY WHEN HE ACTIVATED THE KNIFE. THERE WAS BLEEDING OBSERVED AS A RESULT OF THE INCIDENT. THEY RESOLVED THE BLEEDING USING A COMPETITOR DEVICE. INTERVENTION: USED ANOTHER HANDPIECE BUT SAME PROBLEM - NO SEALING. PATIENT STATUS: THERE WAS NO CONSEQUENCE FOR THE PATIENT.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: GYN EVENT DESCRIPTION: COMPLAINT 1 OF 3: (B)(4) COMPLAINT 2 OF 3: (B)(4) COMPLAINT 3 OF 3: (B)(4) MODEL IS EB15 OR EA020. IT IS UNKNOWN IF A PATIENT INJURY OR ILLNESS OCCURRED. USED ANOTHER HANDPIECE BUT SAME PROBLEM - NO SEALING ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 4AUG23: LOT NO: 1484419, SURGERY: GYN I WILL CHECK UP MORE SPECIFIC. NO PATIENT WAS HURT. THE HOSPITAL HAS KEPT THE HANDLE USED IN THE SURGERY AT THE MEDICO DEPARTMENT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 7AUG23: I HAVE BEEN IN CONTACT WHIT THE DOCTOR [NAME REDACTED] THIS MORNING, HE IS THE ONE USING THE HANDLES. HE INFORMS ME THAT BOTH HANDLES DIDN´T ACTIVATE WHEN HE WAS USING THE ACTIVATE BUTTON. BUT ACTIVATION DID START WHEN HE WAS USING THE KNIFE. I INFORMED HIM THAT WE HAVE TESTED THE 2 HANDLES USED AT THE DEPARTMENT LAST FRIDAY AND WE COULD NOT FIND ANY ISSUES WITH THE HANDLES. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA PHONE 8AUG23: THE INCIDENT OCCURRED WITH 3 UNITS OF EB217 LOT 1484419. ONE EVENT OCCURRED ON (B)(6) 2023 AND 2 EVENTS OCCURRED ON (B)(6) 2023. THE 3 UNITS EXPERIENCED THE SAME PROBLEM, AS FAR AS I KNOW. THE LOT NUMBER OF THE EVENT UNITS IS 1484419. NO PATIENT INJURY OCCURRED. THERE WERE NO CONSEQUENCES ON THE PATIENT. NAME OF THE PROCEDURE IS UNKNOWN. TYPE OF TISSUE BEING GRASPED WHEN THE EVENT HAPPENED IS UNKNOWN. THE EXPERIENCE WAS OBSERVED IMMEDIATELY AFTER USING THE DEVICE. IT IS UNKNOWN IF THE READY MESSAGE WAS DISPLAYED ON THE SCREEN, OR IF THEY RECEIVED ANY ALARMS. THE ACTIVATION TONE WAS HEARD BUT ONLY WHEN HE ACTIVATED THE KNIFE. THERE WAS BLEEDING OBSERVED AS A RESULT OF THE INCIDENT. THEY RESOLVED THE BLEEDING USING A COMPETITOR DEVICE. INTERVENTION: USED ANOTHER HANDPIECE BUT SAME PROBLEM - NO SEALING. PATIENT STATUS: THERE WAS NO CONSEQUENCE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51680 EB217, VOYANT MARYLAND FUSION 23CM, 6/BX ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI APPLIED MEDICAL RESOURCES EB217 1484419 00607915139377

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GENERATOR