BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CFR74, 12X100 KII OPT ADVFIX HDL 6/BX

    MDR report key: 14060764 · Received April 8, 2022

    Report

    Report Number
    2027111-2022-00549
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Report Date
    September 19, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915125745
    PMA / PMN Number
    K083638
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    A PORTION OF THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION, ALONG WITH A CLEAR FRAGMENT. VISUAL INSPECTION CONFIRMED THE COMPLAINANT¿S EXPERIENCE OF A DAMAGED OBTURATOR. THE CLEAR FRAGMENT WAS IDENTIFIED TO BE A PORTION OF THE OBTURATOR SHAFT CONTAINED WITHIN THE OBTURATOR. BASED ON THE CONDITION OF THE RETURNED UNIT, IT IS MOST LIKELY THAT A PROTRUDING PIECE OF THE OBTURATOR FRAGMENTED DUE TO THE INSERTION OF THE SCOPE. THIS EVENT WAS INITIALLY REPORTED BASED ON THE DESCRIPTION OF THE EVENT. HOWEVER, BASED ON THE EVALUATION OF THE RETURNED UNIT, APPLIED MEDICAL DETERMINED THAT THIS EVENT IS NOT REPORTABLE AS AN OBTURATOR FRAGMENT CONTAINED WITHIN THE OBTURATOR IS UNLIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: WHEN THE TROCAR WAS USED A PORTION OF THE INSIDE OF THE TROCAR CAME OFF ON THE INSIDE OF THE TROCAR. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 30MAR2022 FROM APPLIED MEDICAL CUSTOMER RELATIONS REPRESENTATIVE: CUSTOMER FROM (B)(6) MEDICAL CENTER CALLED TO REPORT THEY COULD NOT VISUALIZE THROUGH THE TROCAR. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 01APR2022 FROM THE FACILITY: CUSTOMER CONFIRMED THERE IS ONLY ONE CFR74 LOT #1425182 COMPLAINT FROM THE FACILITY. PRODUCT WAS PICKED UP BY APPLIED FIELD TEAM. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 07APR2022 FROM THE FACILITY: SURGICAL TECH REPORTS INSERTING SCOPE TO BE DIFFICULT AT TIMES. WHILE INSERTING THE SCOPE A PIECE OF THE CANNULA/INTRODUCER CHIPPED OFF AND FELL DOWN IN TO THE TIP OF THE TROCAR RESULTING IN DECREASED VIEW. REPORTED TO BE SMALL PLASTIC PIECE (BELIEVE TO BE CANNULA/INTRODUCER NOT SEAL FRAGMENT). NO INJURY TO REPORT. USED ANOTHER CFR74 TROCAR TO COMPLETE THE CASE. 10MM SCOPE WAS INSIDE OF THE CANNULA AT THE TIME OF THE INCIDENT. LOT TRACES TO 1003630. PRODUCT IS AVAILABLE FOR RETURN. TYPE OF INTERVENTION: USED ANOTHER CFR74 TROCAR TO COMPLETE THE CASE. PATIENT STATUS: NO INJURY TO REPORT.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: WHEN THE TROCAR WAS USED A PORTION OF THE INSIDE OF THE TROCAR CAME OFF ON THE INSIDE OF THE TROCAR. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 30MAR2022 FROM APPLIED MEDICAL CUSTOMER RELATIONS REPRESENTATIVE: CUSTOMER FROM LEXINGTON MEDICAL CENTER CALLED TO REPORT THEY COULD NOT VISUALIZE THROUGH THE TROCAR. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 01APR2022 FROM THE FACILITY: CUSTOMER CONFIRMED THERE IS ONLY ONE CFR74 LOT #1425182 COMPLAINT FROM THE FACILITY. PRODUCT WAS PICKED UP BY APPLIED FIELD TEAM. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 07APR2022 FROM THE FACILITY: SURGICAL TECH REPORTS INSERTING SCOPE TO BE DIFFICULT AT TIMES. WHILE INSERTING THE SCOPE A PIECE OF THE CANNULA/INTRODUCER CHIPPED OFF AND FELL DOWN IN TO THE TIP OF THE TROCAR RESULTING IN DECREASED VIEW. REPORTED TO BE SMALL PLASTIC PIECE (BELIEVE TO BE CANNULA/INTRODUCER NOT SEAL FRAGMENT). NO INJURY TO REPORT. USED ANOTHER CFR74 TROCAR TO COMPLETE THE CASE. 10MM SCOPE WAS INSIDE OF THE CANNULA AT THE TIME OF THE INCIDENT. LOT TRACES TO 1003630. THE PRODUCT IS AVAILABLE FOR RETURN. TYPE OF INTERVENTION: USED ANOTHER CFR74 TROCAR TO COMPLETE THE CASE. PATIENT STATUS: NO INJURY TO REPORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159809 CFR74, 12X100 KII OPT ADVFIX HDL 6/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CFR74 1425182 00607915125745

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown