BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C0Q19, KII 8X100 Z-THR OPT SYS 6/BX

    MDR report key: 9772149 · Received February 28, 2020

    Report

    Report Number
    2027111-2020-00397
    Event Type
    Malfunction
    Date Received
    February 28, 2020
    Date of Event
    February 7, 2020
    Report Date
    March 3, 2020
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915115920
    PMA / PMN Number
    K060096
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS TO FOLLOW UP MEDWATCH REPORT #MW5093044.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAP SACROCOLPOPEXY. EVENT DESCRIPTION: REP WAS NOT PRESENT FOR THE CASE. [NAME] WAS PERFORMING A LAP SACROCOLPOPEXY. HE SAID THEY NOTICED THAT THE ENTIRE CLEAR SHIELD HAD COME OUT AND WAS INSIDE THE PATIENT. THE SHIELD WAS RETRIEVED AND GRABBED ANOTHER TROCAR TO FINISH THE CASE. [NAME] THOUGHT THAT HE SNAGGED THE SEAL GOING BACK AND FORTH WITH THE NEEDLE. THE NEEDLE WAS PASSED BACK AND FORTH AROUND 15 TIMES. THERE WAS NO PATIENT INJURY. THE TROCAR WAS DISCARDED AFTER THE CASE. ADDITIONAL INFORMATION WAS RECEIVED FROM FDA MEDWATCH, MW# 5093044, VIA MAIL ON MARCH 2ND, 2020: EVENT DESCRIPTION: "PLASTIC INSIDE OF TROCAR BROKE OFF AND WAS FOUND IN ABDOMEN DURING PROCEDURE. THE PIECE WAS REMOVED FROM ABDOMEN IMMEDIATELY. TROCAR WAS INSPECTED, REMOVED FROM THE PT AND REPLACED WITH A NEW ONE. PROCEDURES: LAPAROSCOPIC SACRAL COLPOPEXY WITH CYSTOSCOPY. OP. NOTE: "IN THE LEFT LOWER QUADRANT, AN 8 MM AND A 5 MM TROCAR WERE PLACED. WE LATER REPLACED THE 8 MM WITH THE 11 MM TROCAR." FDA SAFETY REPORT ID# (B)(4)." TYPE OF INTERVENTION: REPLACED WITH A NEW TROCAR PATIENT STATUS: NO PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, TESTING WAS UNABLE TO BE PERFORMED AND THE COMPLAINANT'S EXPERIENCE OF SEAL COMPONENT SEPARATION COULD NOT BE REPLICATED OR CONFIRMED. BASED ON THE DESCRIPTION OF THE EVENT, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY NON-AXIAL INSERTION OR REMOVAL OF ASYMMETRICAL INSTRUMENTATION (NEEDLE) THROUGH THE TROCAR. APPLIED MEDICAL'S INSTRUCTIONS FOR USE (IFU) STATES THAT, "EXTRA CARE SHOULD BE USED WHEN INSERTING ANGULAR AND ASYMMETRICAL INSTRUMENTS, SUCH AS 'J' HOOKS AND CLIP APPLIERS. ALL INSTRUMENTS SHOULD BE CENTERED AXIALLY WHEN INSERTED THROUGH THE SEAL TO PREVENT TEARING."

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: LAP SACROCOLPOPEXY. EVENT DESCRIPTION: REP WAS NOT PRESENT FOR THE CASE. [NAME] WAS PERFORMING A LAP SACROCOLPOPEXY. HE SAID THEY NOTICED THAT THE ENTIRE CLEAR SHIELD HAD COME OUT AND WAS INSIDE THE PATIENT. THE SHIELD WAS RETRIEVED AND GRABBED ANOTHER TROCAR TO FINISH THE CASE. [NAME] THOUGHT THAT HE SNAGGED THE SEAL GOING BACK AND FORTH WITH THE NEEDLE. THE NEEDLE WAS PASSED BACK AND FORTH AROUND 15 TIMES. THERE WAS NO PATIENT INJURY. THE TROCAR WAS DISCARDED AFTER THE CASE. TYPE OF INTERVENTION: REPLACED WITH A NEW TROCAR. PATIENT STATUS: NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233003 C0Q19, KII 8X100 Z-THR OPT SYS 6/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES C0Q19 1374783 00607915115920

    Patients

    Seq Age Sex Outcome Treatment
    1 NEEDLE