BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CTF73, 12X100 KII FIOS ZTHR 6/BX

    MDR report key: 9632841 · Received January 27, 2020

    Report

    Report Number
    2027111-2020-00332
    Event Type
    Malfunction
    Date Received
    January 27, 2020
    Date of Event
    December 31, 2019
    Report Date
    March 18, 2020
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    PMA / PMN Number
    K041795
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. HOWEVER, A PHOTO OF THE EVENT UNIT WAS PROVIDED, WHICH CONFIRMED THE COMPLAINANT'S EXPERIENCE OF A FRACTURED CANNULA. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. THIS REPORT IS TO FOLLOW UP MEDWATCH #MW5092684.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAPAROSCOPIC GASTRIC BYPASS. EVENT DESCRIPTION: REP. WASN'T PRESENT FOR THE CASE AND STATED THAT THE TROCAR BROKE TOWARDS THE END OF THE CASE AS IT WAS BEING USED. IT WASN'T BEING REMOVED FROM THE BODY AT THE TIME OF BREAKAGE. REP THINKS IT WAS THE CANNULA THAT BROKE, THOUGH IT HAS BEEN CONFIRMED THAT NO PIECES FELL INTO THE ABDOMINAL CAVITY OF THE PATIENT. TO COMPLETE THE CASE, THE TROCAR WAS REPLACED. THERE WAS NO PATIENT INJURY, THOUGH IT WAS MENTIONED BY THE REP. THAT AFTER THE PATIENT LEFT SURGERY, THEY EXPERIENCED SOME "COMPLICATIONS - WEAKNESS ON ONE SIDE OF THE BODY". REP. ALSO MENTIONED THAT THE RISK MANAGEMENT DEPARTMENT AT THE HOSPITAL DOESN'T ATTRIBUTE THE COMPLICATIONS TO THE TROCAR AND IS UNRELATED. ADDITIONAL INFORMATION WAS RECEIVED FROM [NAME], RN, DIRECTOR OF RISK MANAGEMENT VIA E-MAIL ON JANUARY 29TH, 2020: IT HAS BEEN CONFIRMED THAT IT WAS THE CANNULA THAT BROKE TOWARDS THE END OF THE SURGERY AND IT OCCURRED ON THE SHAFT OF THE CANNULA. ACCORDING TO THE SURGEON, "HE IS UNSURE HOW THE BREAK OCCURRED." THEY'RE UNAWARE OF ANY CONCOMITANT DEVICES. THE BROKEN DEVICE WAS NOTICED BY THE SURGEON. LOT NUMBER IS NOT AVAILABLE AS THE PACKAGING WAS DISCARDED. ADDITIONAL INFORMATION WAS RECEIVED FROM FDA MEDWATCH REPORT, MW# 5092684, VIA MAIL ON FEBRUARY 20TH, 2020: THE EVENT DATE IS 31DEC2019. THE EVENT REPORT TYPE IS A MALFUNCTION AND THERE WAS NO ADVERSE EVENT. EVENT DESCRIPTION: "DURING A BARIATRIC GASTRIC BYPASS, THE APPLIED CTF73 TROCAR BROKE AT THE SHAFT OF THE CANNULA. THIS OCCURRED TOWARD THE END OF THE CASE REQUIRING THE SURGEON TO USE ANOTHER TROCAR TO COMPLETE THE CASE AND AN X-RAY WAS DONE INTRAOPERATIVELY. FDA SAFETY REPORT ID # (B)(4)." INTERVENTION: TROCAR WAS REPLACED TO COMPLETE THE CASE. PATIENT STATUS: NO PATIENT INJURY OCCURRED.

    Additional Manufacturer Narrative · 1

    THE EVENT DEVICE IS ANTICIPATED TO BE RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: LAPAROSCOPIC GASTRIC BYPASS. EVENT DESCRIPTION: REP. WASN'T PRESENT FOR THE CASE AND STATED THAT THE TROCAR BROKE TOWARDS THE END OF THE CASE AS IT WAS BEING USED. IT WASN'T BEING REMOVED FROM THE BODY AT THE TIME OF BREAKAGE. REP THINKS IT WAS THE CANNULA THAT BROKE, THOUGH IT HAS BEEN CONFIRMED THAT NO PIECES FELL INTO THE ABDOMINAL CAVITY OF THE PATIENT. TO COMPLETE THE CASE, THE TROCAR WAS REPLACED. THERE WAS NO PATIENT INJURY, THOUGH IT WAS MENTIONED BY THE REP. THAT AFTER THE PATIENT LEFT SURGERY, THEY EXPERIENCED SOME "COMPLICATIONS - WEAKNESS ON ONE SIDE OF THE BODY". REP. ALSO MENTIONED THAT THE RISK MANAGEMENT DEPARTMENT AT THE HOSPITAL DOESN'T ATTRIBUTE THE COMPLICATIONS TO THE TROCAR AND IS UNRELATED. THE PRODUCT IS AVAILABLE FOR RETURN. TYPE OF INTERVENTION: TROCAR WAS REPLACED TO COMPLETE THE CASE. PATIENT STATUS: NO PATIENT INJURY OCCURRED [ASSOCIATED WITH THE COMPLAINT EVENT].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97712 CTF73, 12X100 KII FIOS ZTHR 6/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CTF73 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR