BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT COMPL.D:10MM L:370MM

    MDR report key: 5973655 · Received September 23, 2016

    Report

    Report Number
    2916714-2016-00761
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Date of Event
    July 22, 2016
    Report Date
    October 19, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    OCW
    PMA / PMN Number
    K962493
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: SOUTH KOREA. IT WAS REPORTED THAT FOLLOWING A CHOLECYSTOTOMY PROCEDURE, THE SURGEON REALIZED THAT THE SCREW FROM THE SHAFT OF THE CLIP APPLIER (PL536R) WAS MISSING. IT WAS DETERMINED THE SCREW IS RETAINED IN THE PATIENT'S BODY. DURING THE SURGERY, THE CLIP APPLIER DISPLAYS ISSUES; THERE WAS DIFFICULTY IN RE-SETTING OF THE CLIP. THERE WAS NO DELAY IN SURGERY WAS REPORTED. NO FURTHER PATIENT HAZARD. NO ADDITIONAL POST-OPERATIVE PROCEDURES PERFORMED TO DATE; SCREW REMAINS IN PATIENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: NO PRODUCT IS AT HAND. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY RELATED TO AN INSUFFICIENT MAINTENANCE OF THE DEVICE. RATIONAL: BASED ON THE INFORMATION AVAILABLE AND OUR QUALITY STANDARDS WE EXCLUDE A MATERIAL OR MANUFACTURER RELATED ERROR. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625738 SHAFT COMPL.D:10MM L:370MM CLIP APPLIER OCW AESCULAP AG PL536R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other