BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20/CA ULTRA NONSTICK 10FT

    MDR report key: 14277340 · Received May 4, 2022

    Report

    Report Number
    1320894-2022-00089
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    April 8, 2022
    Report Date
    May 23, 2022
    Manufacturer
    WICKIMED SUPPLY COMPANY LIMITED
    Product Code
    GEI
    PMA / PMN Number
    K103375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    AN EVALUATION FROM THE MANUFACTURER OF THE SAME BATCH (LOT:111020) OF BATCH RECORD OF RESERVED SAMPLES PLPUL2020 PLUMEPEN ELITE PENCIL (10FT), IS QUALIFIED. SIMULATED PULLING AND INSERTING TEST FOR THE LATEST BATCH (LOT:111020) OF 2 PIECES RESERVED SAMPLES PLPUL202020/CA ULTRA NONSTICK 10FT, TO INSERT AND PULL FOR 10 TIMES, THE PLASTIC PART COULD HOLD ELECTRODE. AFTER BEING INSERTING AND PULLING TEST, SIMULATED FUNCTION TEST FOR THE 2 PIECES RESERVED SAMPLES PLPUL202020/CA ULTRA NONSTICK 10FT (LOT: 111020), CONNECTED WITH THE HIGH FREQUENCY COMPATIBLE GENERATOR AND ACCESSORIES TO SET THE OUTPUT POWER OF CUTTING BY 60W COAGULATION BY 55W, THEN RESPECTIVELY PRESSED THE SWITCH BUTTON OF CUTTING AND COAGULATION, WHICH CAN BE NORMALLY FUNCTIONED AND THE PLASTIC PART COULD HOLD ELECTRODE, THUS, IT CAN BE JUDGED AS QUALIFIED PRODUCT. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE DEVICE IS NOT MANUFACTURED BY CONMED. A TWO-YEAR LOT HISTORY REVIEW SHOWS THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 34 COMPLAINTS, REGARDING 55 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 4,014,280 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.00001 PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED TO CONFIRM THAT BLADE IS COMPLETELY INSERTED AND SECURE BEFORE ACTIVATING PENCIL. NEVER FORCE THE BLADE INTO THE PENCIL. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE, PLPUL2020, 20/CA ULTRA NONSTICK 10FT WAS BEING USED DURING A TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO OOPHORECTOMY AND STAGING PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED THAT, ¿WILL NOT HOLD ELECTRODE / INSERTION OF ELECTRODE IS TOO DEEP ALSO.¿ UPON FURTHER ASSESSMENT IT WAS FOUND THAT DR. (B)(6) GYN/ONCOLOGY WAS PERFORMING THE SURGERY WHEN "PER THE SURGEON, WHILE USING THE ELECTRODE THE ELECTRODE CAME OFF THE DEVICE AND WHEN SHE PUT IT BACK IN, IT WENT DEEPER INSIDE THE DEVICE, PER THIS SAME SURGEON THIS HAD HAPPENED TO HER ONCE BEFORE WITH THE SAME DEVICE. SHE WAS CONCERNED THAT THE TIP COULD BECOME A RETAINED FOREIGN BODY IF LOST IN THE BODY AND ALSO CONCERNED AS TO WHY IT GOT SHOVED IN SO FAR." THEREFORE, THE DEVICE BROKE DURING SURGERY WHILE IN THE STERILE FIELD, WHEN THE "THE TIP DETACHED/ CAME OFF OF THE HANDPIECE AND FELL INTO THE PATIENT'S OPEN BODY, IT WAS RETRIEVED RIGHT AWAY. DR. (B)(6) USED HER HAND TO RETRIEVE IT". ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER WAS THAT THE ELECTRODE WAS INSERTED ONCE AFTER IT FELL OUT. THE SURGERY WAS COMPLETED AFTER MINOR DELAY DUE TO THE CHANGING OUT OF THE CAUTERY DEVICE. THE PATIENT WAS NOT INJURED, NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED, AND NO EXTENDED HOSPITALIZATION WAS NECESSARY. PATIENT WAS SAID TO BE ¿FINE/NORMAL". THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE, PLPUL2020, 20/CA ULTRA NONSTICK 10FT WAS BEING USED DURING A TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO OOPHORECTOMY AND STAGING PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED THAT, ¿WILL NOT HOLD ELECTRODE / INSERTION OF ELECTRODE IS TOO DEEP ALSO.¿ UPON FURTHER ASSESSMENT IT WAS FOUND THAT DR. (B)(6) GYN/ONCOLOGY WAS PERFORMING THE SURGERY WHEN "PER THE SURGEON, WHILE USING THE ELECTRODE THE ELECTRODE CAME OFF THE DEVICE AND WHEN SHE PUT IT BACK IN, IT WENT DEEPER INSIDE THE DEVICE, PER THIS SAME SURGEON THIS HAD HAPPENED TO HER ONCE BEFORE WITH THE SAME DEVICE. SHE WAS CONCERNED THAT THE TIP COULD BECOME A RETAINED FOREIGN BODY IF LOST IN THE BODY AND ALSO CONCERNED AS TO WHY IT GOT SHOVED IN SO FAR." THEREFORE, THE DEVICE BROKE DURING SURGERY WHILE IN THE STERILE FIELD, WHEN THE "THE TIP DETACHED/ CAME OFF OF THE HANDPIECE AND FELL INTO THE PATIENT'S OPEN BODY, IT WAS RETRIEVED RIGHT AWAY. DR. AMNEUS USED HER HAND TO RETRIEVE IT". ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER WAS THAT THE ELECTRODE WAS INSERTED ONCE AFTER IT FELL OUT. THE SURGERY WAS COMPLETED AFTER MINOR DELAY DUE TO THE CHANGING OUT OF THE CAUTERY DEVICE. THE PATIENT WAS NOT INJURED, NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED, AND NO EXTENDED HOSPITALIZATION WAS NECESSARY. PATIENT WAS SAID TO BE ¿FINE/NORMAL". THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577617 20/CA ULTRA NONSTICK 10FT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI WICKIMED SUPPLY COMPANY LIMITED 111020

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female