BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER

    MDR report key: 16256378 · Received January 27, 2023

    Report

    Report Number
    2647580-2023-00347
    Event Type
    Malfunction
    Date Received
    January 27, 2023
    Date of Event
    January 12, 2023
    Report Date
    January 27, 2023
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GCJ
    UDI-DI
    10884521545328
    PMA / PMN Number
    K151356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: SMSBTRNDX - SM PRO SMSBTRNDX ACCESS DISSECTOR SYSTEM, LOT#: UNKNOWN SMSBTRNDX - SM PRO SMSBTRNDX ACCESS DISSECTOR SYSTEM, LOT#: P2E0272 SMSBTRNDX - SM PRO SMSBTRNDX ACCESS DISSECTOR SYSTEM, LOT#: P2H0012. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN TESTING THE DEVICE, THE BALLOON WAS DISTORTED OR HAD AN UNUSUAL SHAPE. WHEN THE DEVICE WAS OPENED, IT WAS SEEN THAT THE FIRST SMALL STRUCTURAL BALLOON WAS LOOSE OR OUT OF SHAPE. IT AS IT LOOSE AND NOT ROLLED UP, THE DEVICE COULD NOT BE PUSHED THROUGH THE TROCAR. THE DEVICE GETS STUCK IN THE TROCAR. THE CUSTOMER TRIED TO GET ONE MORE DEVICE THROUGH THE TROCAR BUT FAILED AS THE BALLOON WAS COMPLETELY LOOSE. THE DEVICE WENT THROUGH THE TROCAR VERY UNCOMFORTABLY. A MOVING MANIPULATION WAS THEN USED TO REMOVE THE DEVICE FROM THE TROCAR. SEVERAL OTHER DEVICES FROM SEVERAL BOXES HAD THE SAME ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484596 SPACEMAKER LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ US SURGICAL PUERTO RICO SMSBTRNDX 10884521545328

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown