BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPILL

    MDR report key: 20047981 · Received August 23, 2024

    Report

    Report Number
    9710107-2024-00141
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    December 22, 2022
    Report Date
    August 23, 2024
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NYV
    UDI-DI
    04260167482705
    PMA / PMN Number
    K092342
    Removal / Correction Number
    F-0418-2023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF REMEDIATION ACTIVITIES ASSOCIATED WITH CAPA # 643143, WHICH IS ADDRESSING MDR REPORTING GU IDANCE FROM FDAS 1995 PREAMBLE, WHICH ENSURES COMPLAINTS RELATED TO CORRECTIONS AND RECALLS WHICH WERE PREVIOUSLY REPORTED TO FDA UNDER 21 CFR 806 ARE NOW REPORTED AS MDRS ; THIS IS NOT A NEW MALFUNCTION/EVENT. VISUAL INSPECTION OF THE DEVICE VIDEO CONFIRMED THE REPORTED CONDITION. A MANUFACTURING FAULT WAS IDENTIFIED DURING PRODUCT ANALYSIS. THE ROOT CAUSE OF THE OBSERVED CONDITION WAS DETERMINED TO BE A RESULT OF A MANUFACTURING ACTIVITY. A PROCESS IMPROVEMENT HAS BEEN INITIATED TO PREVENT THIS CONDITION FROM RECURRING. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PRODUCT WAS RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE BAR HAD BUGS INSIDE THE PACKAGE WHEN OPENED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312311 SMARTPILL GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE NYV GIVEN IMAGING LTD., YOQNEAM FGS-0505 74800B 04260167482705

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown