BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELAN 4 MIS SLEEVE F/1-RING HANDPIECES

    MDR report key: 8011404 · Received October 28, 2018

    Report

    Report Number
    9610612-2018-00480
    Event Type
    Injury
    Date Received
    October 28, 2018
    Date of Event
    September 29, 2018
    Report Date
    December 10, 2018
    Manufacturer
    AESCULAP AG
    Product Code
    HBC
    PMA / PMN Number
    SEE H. 10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    POST-OPERATIVE MEDICAL INTERVENTION WAS NECESSARY OF AN X-RAY PICTURE. THE PRODUCT IS IN GOOD CONDITION, BUT THE SPRING IS CLEARLY MISSING INSIDE THE SLEEVE. AFTER CONSULTING R&D, IT IS POSSIBLE THAT A WRONG ANGLE DURING POSITIONING OF THE SLEEVE IN COMBINATION WITH TOO HIGH FORCES CAN DAMAGE THE SPRING WHICH COULD LEAD TO A LOOSENING. THE FAILURE IS PROBABLY USAGE RELATED, ASSOCIATED WITH A POTENTIAL DESIGN LACK. HANDLING FAILURE LED TO THE LOOSENING OF THE SPRING. THERE IS A POSSIBILITY OF THE DESIGN LACK WHICH SHOULD BE OPTIMIZED. A PRODUCT SAFETY CASE HAS BEEN REQUESTED. NO CAPA WILL BE NECESSARY.

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING SIMILAR DEVICE ELAN 4 ELECTRIC MOTOR SYSTEM: K152960 PENDING FURTHER INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL TO THE COMPANY SALES REPRESENTATIVE "DURING A SPINAL PROCEDURE, THE COMPLAINT PRODUCT GB862P WAS NOT SECURED ENOUGH AND LOOSENED WHEN DRILLING. AFTER THE SURGERY, IT WAS FOUND THAT A SPRING INSIDE THE PRODUCT WAS MISSING. THE CUSTOMER COULD NOT FIND IT. ALTHOUGH CHECKING THE PICTURES OF THE PROCEDURE, THE SPRING WAS NOT SEEN INSIDE PATIENT." ABSENCE OF THE SPRING WAS ONLY NOTICED AFTER THE SURGICAL PROCEDURE. SEARCH WAS PERFORMED FOR THE SPRING IN THE OPERATION ROOM AFTER THE SURGICAL PROCEDURE. THE CUSTOMER WAS NOT SURE WHEN THE SPRING WAS MISSING. AN X-RAY EXAMINATION WAS PERFORMED, ON (B)(6) 2018 TO VERIFY IF THE SPRING WAS RETAINED IN THE PATIENT. THE X-RAY SHOWED NO SIGN OF THE SPRING OBSERVED IN THE PATIENT'S BODY. NO INFORMATION ABOUT THE PATIENT IS REPORTED. THE X-RAY PHOTO IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852632 ELAN 4 MIS SLEEVE F/1-RING HANDPIECES HIGH SPEED POWER SYSTEMS HBC AESCULAP AG GB862P

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention