BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    SUTURE PASSOR PRO/RSG-14

    MDR report key: 17584138 · Received August 21, 2023

    Report

    Report Number
    3010437008-2023-00004
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    August 29, 2018
    Report Date
    June 30, 2023
    Manufacturer
    ADVANCED MEDICAL DESIGN CO., LTD.
    Product Code
    HCF
    UDI-DI
    0934996700366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTOR HAS BEEN INFORMED ON 15THJUNE 2018 AND REQUESTED TO OBTAIN FURTHER INFORMATION REGARDING THE REPORTED ISSUE AND TO ARRANGE DAMAGED DEVICE TO BE RETURNED FOR INVESTIGATION. HOWEVER, THE DAMAGED DEVICE WAS ALREADY REMOVED FROM STERILE FIELD AND DISPOSED BY THE END USER PRIOR TO THE OPERATION AND THEREFORE, DEVICE COULD NOT BE RETURNED FOR FURTHER INVESTIGATION. NO PHOTOS OF THE DAMAGED DEVICE WERE PROVIDED BY THE COMPLAINANT. BASED ON THE LOT NUMBER IDENTIFICATION PROVIDED BY THE DISTRIBUTOR (LOT#1726156) AND LIMITED INFORMATION REGARDING THE REPORT ISSUE, INVESTIGATION WAS CONDUCTED. THE DEVICE WAS BROKEN BEFORE THE SURGEON ATTEMPTED TO USE IT AND THE SURGEON NOTICED THE OUTER SHEATH PULLED APART FROM THE PLASTIC PORTION OF THE HANDLE. THE SEPARATION OF THE OUTER SHEATH CAUSED THE PLUNGER TO NOT BE ACTUATED AND THEREFORE, THE JAWS COULD NOT BE OPENED TO GRASP THE SUTURE. A REVIEW OF THE CURRENT MANUFACTURING PROCESSES WAS PERFORMED BY ADVANCED MEDICAL DESIGN CO. LTD (SPECIFICATION DEVELOPER, MANUFACTURER). IT WAS IDENTIFIED THAT THE ASSEMBLY PROCESS OF SUTURE PASSOR HANDLE AND OUTER CANNULA WITH UV GLUE COULD POTENTIALLY CONTRIBUTE TO THIS REPORTED PROBLEM. REVIEWS WERE PERFORMED BASED ON APPENDIX 3 (MP-P100, VERSION NUMBER: 4) AND APPENDIX 4 (AMDF063017-02, REVISION A) TO ASSESS THE ADEQUACY OF CURRENT MANUFACTURING PARAMETERS AND SPECIFICATIONS. THE CURRENT MANUFACTURING PARAMETERS AND SPECIFICATIONS FOR UV GLUE CURING PROCESS WERE VERIFIED TO BE ADEQUATE. APPENDIX 1 (QA-P36, VERSION NUMBER: 4) WAS ALSO REVIEWED IN CONJUNCTION WITH APPENDICES 3 AND 4. IT WAS CONCLUDED THAT THE CURRENT ASSEMBLY PROCESS OF SUTURE PASSOR HANDLE AND OUTER CANNULA WITH UV GLUE AND QUALITY TESTS IN ACCORDANCE WITH APPENDIX 1 COULD NOT HAVE POSSIBLY CONTRIBUTED TO THE REPORTED PROBLEM OF SEPARATION OF CANNULA FROM THE HANDLE. DUE TO LIMITED INFORMATION PROVIDED BY THE COMPLAINANT, NO PHOTOS AND UNAVAILABLE DEVICE THAT WAS NOT RETURNED BY COMPLAINANT, LIMITED INVESTIGATION COULD ONLY BE PERFORMED BY ADVANCED MEDICAL DESIGN CO. LTD. THE INVESTIGATION SCOPE COVERED A REVIEW OF THE MANUFACTURING BATCH RECORDS, A TEST THAT WAS PERFORMED ON A RETENTION SAMPLE FROM AFFECTED LOT# 1726156, A REVIEW OF THE CURRENT MANUFACTURING PROCESSES AND ASSOCIATED QUALITY TESTS. 1) A REVIEW OF THE MANUFACTURING BATCH RECORD OF AFFECTED LOT#1726156 (INCLUDING OUTER CANNULA PUSH FORCE TEST RECORDS) WAS CONDUCTED AND THIS BATCH RECORD INDICATED THAT ALL DEVICES WERE ACCEPTED AND RELEASED ACCORDING TO DEVICE SPECIFICATIONS. THE DATE OF MANUFACTURE OF THIS BATCH WAS IDENTIFIED AS 30TH JANUARY 2018.THE NUMBER OF BATCH RECORDS RELEASED FOR THIS DEVICE WAS 12 FOR YEAR 2017 AND 4 BATCH RECORDS RELEASED IN 2018. ALL BATCH RECORDS WERE REVIEWED AND THESE BATCH RECORDS INDICATED THAT THERE WERE NO PRODUCTS NONCONFORMITIES AND NO NONCONFORMING MANUFACTURING PROCESSES THAT COULD CAUSE THE SEPARATION OF THE OUTER SHEATH FROM THE HANDLE OF THE DEVICE. 2) THE RETENTION SAMPLE FROM THE AFFECTED LOT #1726156 WAS RETRIEVED AND TESTED BY ADVANCED MEDICAL DESIGN CO LTD. VISUAL INSPECTION WAS PERFORMED TO CONFIRM THAT THERE WAS NO DAMAGE OF THE DEVICE. A PUSH FORCE TEST ON OUTER CANNULA WAS CONDUCTED TO CONFIRM THAT THE DEVICE WAS ACCEPTABLE AS PER THE ACCEPTANCE CRITERIA OF >=10 KGF IN ACCORDANCE WITH THE REQUIREMENTS OF APPENDIX 2 (QT18091001, VERSION NUMBER: 1) 3) A REVIEW OF THE CURRENT MANUFACTURING PROCESSES WAS PERFORMED BY ADVANCED MEDICAL DESIGN CO. LTD (SPECIFICATION DEVELOPER, MANUFACTURER). IT WAS IDENTIFIED THAT THE ASSEMBLY PROCESS OF SUTURE PASSOR HANDLE AND OUTER CANNULA WITH UV GLUE COULD POTENTIALLY CONTRIBUTE TO THIS REPORTED PROBLEM. REVIEWS WERE PERFORMED BASED ON APPENDIX 3 (MP-P100, VERSION NUMBER: 4) AND APPENDIX 4 (AMDF063017-02, REVISION A) TO ASSESS THE ADEQUACY OF CURRENT MANUFACTURING PARAMETERS AND SPECIFICATIONS. THE CURRENT MANUFACTURING PARAMETERS AND SPECIFICATIONS FOR UV GLUE CURING PROCESS WERE VERIFIED TO BE ADEQUATE. APPENDIX 1 (QA-P36, VERSION NUMBER: 4) WAS ALSO REVIEWED IN CONJUNCTION WITH APPENDICES 3 AND 4. IT WAS CONCLUDED THAT THE CURRENT ASSEMBLY PROCESS OF SUTURE PASSOR HANDLE AND OUTER CANNULA WITH UV GLUE AND QUALITY TESTS IN ACCORDANCE WITH APPENDIX 1 COULD NOT HAVE POSSIBLY CONTRIBUTED TO THE REPORTED PROBLEM OF SEPARATION OF CANNULA FROM THE HANDLE. SUMMARY DUE TO LIMITED INFORMATION PROVIDED BY THE COMPLAINANT, NO PHOTOS AND UNAVAILABLE DEVICE THAT WAS NOT RETURNED BY COMPLAINANT, LIMITED INVESTIGATION COULD ONLY BE PERFORMED BY ADVANCED MEDICAL DESIGN CO. LTD.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: CARTER THOMASON CLOSURE DEVICE USED FOR OPEN HERNIA REPAIR. WHEN DOCTOR ATTEMPTED TO USE IT, SHE NOTICED THE OUTER SHEATH PULLED APART FROM THE PLASTIC PORTION OF HANDLE. THE DEVICE WAS TAKEN OFF TABLE AND ISOLATED.EVENT DESCRIPTION: CARTER THOMASON CLOSURE DEVICE USED FOR OPEN HERNIA REPAIR. WHEN DOCTOR ATTEMPTED TO USE IT, SHE NOTICED THE OUTER SHEATH PULLED APART FROM THE PLASTIC PORTION OF HANDLE. THE DEVICE WAS TAKEN OFF TABLE AND ISOLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483506 SUTURE PASSOR PRO/RSG-14 SUTURE PASSER HCF ADVANCED MEDICAL DESIGN CO., LTD. RSG-14 1726156 0934996700366

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other