BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CTR34, 11X100 KII OPT ZTHR HDL 6/BX

    MDR report key: 15153841 · Received August 2, 2022

    Report

    Report Number
    2027111-2022-00679
    Event Type
    Malfunction
    Date Received
    August 2, 2022
    Report Date
    September 22, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915124243
    PMA / PMN Number
    K060096
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. TESTING WAS PERFORMED ON THE EVENT UNIT, WHICH CONFIRMED THE COMPLAINANT¿S EXPERIENCE OF IMPROPER FIT. UPON CLOSER INSPECTION, THE OBTURATOR WAS OBSERVED TO HAVE A MISALIGNED FEATURE INSIDE THE OBTURATOR. BASED ON THE CONDITION OF THE RETURNED UNIT, THE REPORTED EVENT WAS CAUSED BY THE MISALIGNED FEATURE, CAUSED BY A MOLDING DEFECT. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. THIS EVENT IS NOT REPORTABLE AS IT IS UNLIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. CORRECTION: UPDATED SECTION H6 COMPONENT CODES TO 887 - MOUNT.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAPAROSCOPIC PROCEDURES: EVENT DESCRIPTION: EVENT 1 OF 5: 2022-001526, EVENT 2 OF 5: 2022-001535, EVENT 3 OF 5: 2022-001536, EVENT 4 OF 5: 2022-001537, EVENT 5 OF 5: 2022-001538. DATE OF EVENT: (B)(6) 2022. THE SURGEON USE THE OPTICAL TECNIC FOR THE FIRT ACCES IN LAPAROSCOPIC PROCEDURES . DURING 2 DIFFERENT PROCEDURES THE OPTURATOR OF THE TROCAR IS TOO SMALL TO HOUSE THE LAPAROSCOPE. THE SURGEON INFORM THAT THE 5 TROCARS HAD THE SAME PROBLEM, BUT SHE DON'T REMEMBER THE MODEL AND THE LOT OF THIS TROCARS. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 15JUNE2022: MODEL: CTR34 LOT: 1424056. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 1JULY2022: BRAND OF LAPAROSCOPE: [BRAND NAME] MODEL OF THE LAPAROSCOPE: 30° OPTICS SIZE: 10MM. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 12JULY2022: THE USER EXPERIENCED INCONSISTENT RESISTANCE DURING INSTRUMENT MANIPULATION. PATIENT STATUS: NO PATIENT INJURY HAS BEEN REPORTED.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAPAROSCOPIC PROCEDURES. EVENT DESCRIPTION: EVENT 1 OF 5: (B)(4) (MFR REPORT 2027111-2022-00679); EVENT 2 OF 5: (B)(4) (MFR REPORT 2027111-2022-00680); EVENT 3 OF 5: (B)(4) (MFR REPORT 2027111-2022-00681); EVENT 4 OF 5: (B)(4) (MFR REPORT 2027111-2022-00682); EVENT 5 OF 5: (B)(4) (MFR REPORT 2027111-2022-00683). DATE OF EVENT: 30-31/05/2022. THE SURGEON USE THE OPTICAL TECNIC FOR THE FIRT ACCES IN LAPAROSCOPIC PROCEDURES . DURING 2 DIFFERENT PROCEDURES THE OPTURATOR OF THE TROCAR IS TOO SMALL TO HOUSE THE LAPAROSCOPE. THE SURGEON INFORM THAT THE 5 TROCARS HAD THE SAME PROBLEM, BUT SHE DON'T REMEMBER THE MODEL AND THE LOT OF THIS TROCARS. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 15JUNE22: MODEL CTR34 LOT 1424056. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 1JULY2022: BRAND OF LAPAROSCOPE: [BRAND NAME] MODEL OF THE LAPAROSCOPE: 30° OPTICS SIZE: 10MM. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 12JULY2022: THE USER EXPERIENCED INCONSISTENT RESISTANCE DURING INSTRUMENT MANIPULATION. PATIENT STATUS: NO PATIENT INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570943 CTR34, 11X100 KII OPT ZTHR HDL 6/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CTR34 1424056 00607915124243

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown [BRAND NAME] LAPAROSCOPE