BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGATURE CLIP 12 MAG.= 144 PCS.

    MDR report key: 6914150 · Received October 4, 2017

    Report

    Report Number
    9610612-2016-00486
    Event Type
    Injury
    Date Received
    October 4, 2017
    Date of Event
    September 7, 2017
    Report Date
    June 18, 2020
    Manufacturer
    AESCULAP AG
    Product Code
    FZP
    PMA / PMN Number
    K081031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. THIS EVALUATION WAS ASSOCIATED WITH XC,100018880, WHICH DOCUMENTED THE CONCOMITANT COMPONENTS. B1 - ADVERSE EVENT ADDED AND CLARIFIED. B5 - DESCRIPTION UPDATED. INVESTIGATION: NO PRODUCT AT HAND. BATCH HISTORY REVIEW: A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE BECAUSE THE BATCH NUMBER IS UNKNOWN. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USER RELATED. RATIONAL: ACCORDING TO THE QUALITY STANDARD, A PRODUCTION ERROR AND A MATERIAL DEFECT CAN BE EXCLUDED. NO CAPA IS NECESSARY.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    CLARIFICATION WAS RECEIVED: THIS ISSUE OCCURRED DURING A PROCEDURE WHILE THE SURGEON WAS DEMONSTRATING THE DEVICE. AN X-RAY WAS TAKEN AND THE "NAIL" WAS NOT VISIBLE IN THE RESULTS.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). THE MAGAZINE CAME AWAY FROM THE APPLIER AT THE THIRD CLIP. A SURGEON REMOVED THE MAGAZINE AND FOUND THAT THE NAIL TO FIX IN APPLIER WAS MISSING. THE FRAGMENT WAS NOT FOUND. THEREFORE THE INCIDENT WAS REPORTED SINCE THERE WAS THE POSSIBILITY THAT THE FRAGMENT REMAINED INSIDE THE PATIENT. COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: PL572T / LIGATURE CLIP 12 MAG.= 144 PCS. PL604R / MULTIF.CLIP APPL. TI-P 5/310 MM F/SM-CLIPS. PL575SU / CHALLENGER TI-P C02-CARTRIDGE ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693133 LIGATURE CLIP 12 MAG.= 144 PCS. ENDOSCOPY FZP AESCULAP AG PL572T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R PL572T / LIGATURE CLIP 12 MAG.= 144 PCS.| PL575SU / CHALLENGER TI-P C02-CARTRIDGE ONLY.| PL604R / MULTIF.CLIP APPL.TI-P 5/310MM F/SM-CLIPS.