BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JA PILLCAM SB3 CAPSULE

    MDR report key: 12923313 · Received December 3, 2021

    Report

    Report Number
    9710107-2021-00489
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    August 23, 2021
    Report Date
    December 29, 2021
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NYV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3: EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DELIVERY SYSTEM WAS NOT RETURNED, BUT THE CAPSULE WAS AVAILABLE FOR EVALUATION. NO INFORMATION REGARDING THE SPECIFIC CUSTOMER ISSUE THAT OCCURRED WITH THE DEVICE WAS AVAILABLE. IT WAS REPORTED THAT THE CAPSULE REMAINED IN THE PATIENT LONGER THAN EXPECTED. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE PATENCY CAPSULE WAS RETAINED IN THE PATIENT'S BODY. THE PATENCY CAPSULE WAS SWALLOWED 2 DAYS BEFORE THE PROCEDURE IN THE EVENING. THERE WAS NO DISCHARGE ON THE DAY OF THE PROCEDURE AND X RAY WAS CHECKED AND CAPSULE WAS NOT REFLECTED. THE PROCEDURE WAS CONTINUED BASED ON THE JUDGEMENT THAT IT WAS DISCHARGE. THE PATENCY CAPSULE STOPPED IN THE SMALL BOWEL AND THE BODY PART HAD ALREADY DISINTEGRATE AND IT WAS NOT REFLECTED ON THE X RAY 30 HOURS AFTER SWALLOWING THE PATENCY CAPSULE. THEY TRIED TO REMOVE THE CAPSULE USING ENDOSCOPE AND IT WAS NOT POSSIBLE. THEY SURGICALLY REMOVED THE CAPSULE FROM THE PATIENT. IT WAS FOUND THAT THE PATIENT HAD STENOSIS IN SMALL INTESTINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825145 JA PILLCAM SB3 CAPSULE GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE NYV GIVEN IMAGING LTD., YOQNEAM FGS-0391-J

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention