BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CFS02, 5X100 KII SLEEVE ADVFIX 12/BX

    MDR report key: 15160939 · Received August 3, 2022

    Report

    Report Number
    2027111-2022-00685
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    July 22, 2022
    Report Date
    October 3, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915117733
    PMA / PMN Number
    K083638
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT IS BEING RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE DESCRIPTION OF THE EVENT AND A PREVIOUS OCCURRENCE, IT IS LIKELY THAT THE NEEDLES USED WERE TOO LARGE TO FIT THROUGH THE TROCAR. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. THIS EVENT WAS INITIALLY REPORTED BASED ON THE DESCRIPTION OF THE EVENT. HOWEVER, BASED ON FURTHER EXAMINATION OF THE EVENT, APPLIED MEDICAL DETERMINED THAT THIS EVENT IS NOT REPORTABLE AS IT IS UNLIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. CORRECTION: THE COMPONENT CODE IN SECTION H6 WAS CORRECTED.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: HYSTERECTOMY. EVENT DESCRIPTION: EVENT 1 OF 2: (B)(4). EVENT 2 OF 2: (B)(4). THE SURGEONS NOTED A "FORCED" PASSAGE OF THE NEEDLES MENTIONED IN THE CFS02 SLEEVE REF. AS A RESULT, THERE WAS NEEDLE RUBBING WITH THE PLASTIC OF THE SLEEVE. THE NEEDLES REMAINED STUCK IN THE TROCAR, SOME OF THEM LOOSENED DURING THE MANIPULATIONS. THIS TYPE OF EVENT OCCURRED TWICE IN 24 HOURS WITH 2 REFERENCES OF THE SLEEVE MENTIONED. NO UNIT OF THIS REFERENCE CFS02 WAS KEPT. NEEDLES USED :[BRAND NAME REDACTED] 2/0 AIGUILLE 31 MM 1/2C REF : JV3016 -[BRAND NAME REDACTED] 0 AIGUILLE 26 MM 1/2C REF : X905H. TYPE OF INTERVENTION: SURGEONS USED ANOTHER CFS02 LOT NUMBER AND EVERYTHING WENT WELL PATIENT STATUS: FINE.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: HYSTERECTOMY. EVENT DESCRIPTION: EVENT 1 OF 2: (B)(4) (REPORT ID 2027111-2022-00685); EVENT 2 OF 2: (B)(4) (REPORT ID 2027111-2022-00686). THE SURGEONS NOTED A "FORCED" PASSAGE OF THE NEEDLES MENTIONED IN THE CFS02 SLEEVE REF. AS A RESULT, THERE WAS NEEDLE RUBBING WITH THE PLASTIC OF THE SLEEVE. THE NEEDLES REMAINED STUCK IN THE TROCAR, SOME OF THEM LOOSENED DURING THE MANIPULATIONS. THIS TYPE OF EVENT OCCURRED TWICE IN 24 HOURS WITH 2 REFERENCES OF THE SLEEVE MENTIONED. NO UNIT OF THIS REFERENCE CFS02 WAS KEPT. NEEDLES USED :[BRAND NAME REDACTED] 2/0 AIGUILLE 31 MM 1/2C REF : JV3016 -[BRAND NAME REDACTED] 0 AIGUILLE 26 MM 1/2C REF : X905H. TYPE OF INTERVENTION: SURGEONS USED ANOTHER CFS02 LOT NUMBER AND EVERYTHING WENT WELL PATIENT STATUS: FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944550 CFS02, 5X100 KII SLEEVE ADVFIX 12/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CFS02 1448394 00607915117733

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NEEDLES