BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CFF05, 5X75 KII FIOS ADV FIX 6/BX

    MDR report key: 10174740 · Received June 19, 2020

    Report

    Report Number
    2027111-2020-00486
    Event Type
    Malfunction
    Date Received
    June 19, 2020
    Date of Event
    May 15, 2020
    Report Date
    August 4, 2020
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915123123
    PMA / PMN Number
    K083638
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED UNIT CONFIRMED THAT A PIECE OF THE SEPTUM, AN INTERNAL RUBBER COMPONENT OF THE SEAL, HAD SEPARATED FROM THE SEAL. THE RUBBER FRAGMENT COMPLETED THE MISSING PORTION ON THE SEPTUM. ENGINEERING ALSO OBSERVED THAT THE SHIELD, AN INTERNAL PLASTIC COMPONENT OF THE SEAL, HAD ALSO SEPARATED FROM THE SEAL. BASED ON THE CONDITION OF THE RETURNED UNIT AND THE DESCRIPTION OF THE EVENT, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY NON-AXIAL INSERTION OR REMOVAL OF ASYMMETRICAL INSTRUMENTS AND/OR MATERIAL 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." SEPTUM FRAGMENTATION IS NOT CONSIDERED TO BE REPORTABLE AS IT IS UNLIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. HOWEVER, THE EVENT IS REPORTABLE DUE TO THE DISLODGED SHIELD.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LADG. EVENT DESCRIPTION: THIS IS A COMPLAINT FROM THE MARKET. PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. DETACHMENT OF THE SEPTUM. REPORT FROM THE SALES REP THE SEPTUM WAS DETACHED FROM SEAL COMPONENT DURING THE PROCEDURE. THE FRAGMENT WAS RECOVERED FROM THE BODY CAVITY. THE CASE WAS COMPLETED WITH THE NEW ONE. INITIAL INVESTIGATION REPORT THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. THE SEPTUM WAS DETACHED FROM THE SEAL COMPONENT. IT WAS FRAGMENTED. THE RETURNED FRAGMENT IS SIMILAR TO THE MISSING SECTION ON THE SEPTUM IN SHAPE. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. THE TYPE OF PROCEDURE WAS UPPER GS SURGERY, LADG. THE OPERATION TIME WAS 3-5 HOURS. THE SURGEON'S SKILL LEVEL WAS MID-CAREER. THE MAIN USAGE OF THE DAMAGED TROCAR WAS AS THE 2ND PORT. [NON-APPLIED] ENERGY DEVICE, GRASPER, SCISSORS AND GAUZE WERE INSERTED/REMOVED INTO/FROM THE DAMAGED TROCAR. THE NUMBER OF INSERTION/REMOVAL WAS 10-30 TIMES. THE DAMAGE WAS FOUND AFTER THE CASE. THE SURGEON(S) AND OR NURSE(S) FOUND THE DAMAGE BY FINDING THE PARTS DURING THE CASE. FELT SOMETHING STUCK. AFTER THE DAMAGE WAS FOUND, REMOVED ALL DAMAGED PARTS. INTRAPERITONEAL IRRIGATION WAS PERFORMED. THIS IS THE FIRST TIME THIS ISSUE HAS HAPPENED AT THE SAME DEPARTMENT/SPECIALTY AT THE HOSPITAL. INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW ONE. PATIENT STATUS: NO PATIENT INJURY.

    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: LADG. EVENT DESCRIPTION: THIS IS A COMPLAINT FROM THE MARKET. PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. DETACHMENT OF THE SEPTUM. REPORT FROM THE SALES REP. THE SEPTUM WAS DETACHED FROM SEAL COMPONENT DURING THE PROCEDURE. THE FRAGMENT WAS RECOVERED FROM THE BODY CAVITY. THE CASE WAS COMPLETED WITH THE NEW ONE. INITIAL INVESTIGATION REPORT THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. THE SEPTUM WAS DETACHED FROM THE SEAL COMPONENT. IT WAS FRAGMENTED. THE RETURNED FRAGMENT IS SIMILAR TO THE MISSING SECTION ON THE SEPTUM IN SHAPE. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. THE TYPE OF PROCEDURE WAS UPPER GS SURGERY, LADG. THE OPERATION TIME WAS 3-5 HOURS. THE SURGEON'S SKILL LEVEL WAS MID-CAREER. THE MAIN USAGE OF THE DAMAGED TROCAR WAS AS THE 2ND PORT. [NON-APPLIED] ENERGY DEVICE, GRASPER, SCISSORS AND GAUZE WERE INSERTED/REMOVED INTO/FROM THE DAMAGED TROCAR. THE NUMBER OF INSERTION/REMOVAL WAS 10-30 TIMES. THE DAMAGE WAS FOUND AFTER THE CASE. THE SURGEON(S) AND OR NURSE(S) FOUND THE DAMAGE BY FINDING THE PARTS DURING THE CASE. FELT SOMETHING STUCK. AFTER THE DAMAGE WAS FOUND, REMOVED ALL DAMAGED PARTS. INTRAPERITONEAL IRRIGATION WAS PERFORMED. THIS IS THE FIRST TIME THIS ISSUE HAS HAPPENED AT THE SAME DEPARTMENT/SPECIALTY AT THE HOSPITAL. INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW ONE. PATIENT STATUS: NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639387 CFF05, 5X75 KII FIOS ADV FIX 6/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CFF05 1373105 00607915123123

    Patients

    Seq Age Sex Outcome Treatment
    1 HD1000I ENERGY DEVICE, GRASPER, SCISSORS AND GAUZE.| HD1000I ENERGY DEVICE, GRASPER, SCISSORS AND GAUZE.