BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMIC ELECTRODE TIP L-HK F/GK372R

    MDR report key: 5471801 · Received March 1, 2016

    Report

    Report Number
    2916714-2016-00149
    Event Type
    Malfunction
    Date Received
    March 1, 2016
    Date of Event
    February 1, 2016
    Report Date
    November 9, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K970541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). DURING GASTRIC BAND PROCEDURE, THE ELECTRODE TIP OF THE DEVICE BROKE OFF INSIDE THE PATIENT. PATIENT X-RAYED, NO FRAGMENT NOTED; HOWEVER, THE TIP WAS NOT RECOVERED. SURGERY DELAYED 30 MINUTES. NO HARM TO THE PATIENT HAS BEEN REPORTED. COMPONENTS OF DEVICE INCLUDE: GK384R / CERAMIC ELECTRODE TIP L-HK F/GK372R (TIP BROKE OFF). CABLE / NON-AESCULAP DEVICE. GK370P / SHAFT ONLY F/MODULAR MONOPOL.ELECTR. GK372R / HANDLE F/MONOPOLAR ELECTRODES 5MM.

    Additional Manufacturer Narrative · 1

    THE RECEIVED ELECTRODE HAD A MANUFACTURE DATE OF 01/01/2011. THE TIP WAS BROKEN OFF. THE ELECTRODE WAS ANALYZED BY DIGITAL MICROSCOPE (KEYENCE-VHX 5000). THIS PRODUCT DOES NOT REQUIRE BATCH MANAGEMENT; REVIEW OF DEVICE QUALITY RECORDS AND MANUFACTURING RECORDS IS NOT POSSIBLE. THE ANALYSIS OF THE FRACTURE PATTERN ILLUSTRATED A FORCED FRACTURE DUE TO OVERLOAD. NO PORES, INCLUSIONS OR FOREIGN BODIES COULD BE FOUND ON THE POINT OF RUPTURE. THIS KIND OF INSTRUMENT IS DESIGNED FOR DELICATE USE ONLY. IT IS LIABLE THAT A MECHANICAL OVERLOAD SITUATION LED TO THE BREAKAGE. BASED ON THE INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE FAILURE IS LIKELY USER RELATED. CORRECTIVE/PREVENTIVE ACTION IS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127317 CERAMIC ELECTRODE TIP L-HK F/GK372R ELECTROSURGICAL DEVICE GEI AESCULAP AG GK384R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other