BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLON DECOMPRESSION SET

    MDR report key: 15751457 · Received November 8, 2022

    Report

    Report Number
    3001845648-2022-00754
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Report Date
    November 8, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION THE CDSG-14-175 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HOWEVER, PRIOR TO DISTRIBUTION ALL CDSG-14-175 DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. REVIEW OF HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING IN RELATION TO INTENDED USE OF THE DEVICE: ¿THIS DEVICE IS INTENDED FOR TREATMENT OF ACUTE NON-TOXIC MEGACOLON, PSEUDO-OBSTRUCTION (OGILVIE'S SYNDROME) AND COLONIC STRICTURES." THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED. AS PER THE IFU, THE INTENDED USE OF THE DEVICE IS FOR "TREATMENT OF ACUTE NON-TOXIC MEGACOLON, PSEUDO-OBSTRUCTION (OGILVIE'S SYNDROME) AND COLONIC STRICTURES." BASED ON THE AVAILABLE INFORMATION, IT IS KNOWN THAT THE DEVICE WAS USED IN THE VOLVULUS AND THIS IS CONSIDERED OFF LABEL USE. SUMMARY COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. PMA/510(K) # K171619.

    Additional Manufacturer Narrative · 0

    PMS 510K # K171619 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2022.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS VIA CRI FORM "¿ CDSG-14-175 MIGRATED 48 HOURS AFTER THE INITIAL PLACEMENT PROCEDURE. THE EVENT WAS REPORTED AS NOT RELATED TO THE COLON DECOMPRESSION SET AND NOT RELATED TO THE STUDY PROCEDURE." THERE WAS NO TREATMENT OF THE EVENT. THE DEVICE WAS REMOVED AT 48 HOURS AND WAS NOT REPLACED. SUCCESS OF TREATMENT WITH THE COLON DECOMPRESSION SET WAS NOT DOCUMENTED. NO OTHER ADVERSE EVENTS WERE REPORTED PRIOR TO THE PATIENT BEING EXITED FROM THE STUDY. FINAL PMCF REPORT RECEIVED ON (B)(6)2022 . IT WAS CONFIRMED BY MEDICAL AFFAIRS THAT THE USE OF CDSG DEVICE IN THE VOLVULUS IS OFF LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334858 COLON DECOMPRESSION SET FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION FEG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown