BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLON DECOMPRESSION SET

    MDR report key: 15751036 · Received November 8, 2022

    Report

    Report Number
    3001845648-2022-00748
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Report Date
    November 15, 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

    PMA/510(K): # K171619. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K171619. DEVICE EVALUATION: THE UNKNOWN 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/CDSM 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 THE INTENDED USE OF THE DEVICE: ¿THE 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. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS DETERMINED. THE INSTRUCTIONS FOR USE STATE THAT THE INTENDED USE FOR THE DEVICE IS FOR THE TREATMENT OF ACUTE NON-TOXIC MEGACOLON, PSEUDO-OBSTRUCTION (OGILVIE'S SYNDROME) AND COLONIC STRICTURES. THE USE OF THE CDSG/CDSM DEVICE IN THE SIGMOID VOLVULUS OR FOR THE TREATMENT OF CLOSTRIDIUM DIFFICILE COLITIS IS 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.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS VIA PMCF FORM "PATIENT¿S TREATED FOR CLOSTRIDIUM DIFFICILE (C. DIFF.) COLITIS OR VOLVULUS/SIGMOID VOLVULUS, WHICH ARE OUTSIDE THE INDICATION FOR USE.¿ THIS IS CONSIDERED OFF-LABEL USE, THIS DEVICE IS UNTENDED FOR TREATMENT OF ACUTE NON-TOXIC MEGACOLON PSEUDO-OBSTRUCTION (OGILVIE¿S SYNDROME) AND COLONIC STRICTURES. PATIENT NUMBERS AS FOLLOWS: (B)(6). 27 PATIENTS IN TOTAL (REFERENCE PR (B)(4) DETAIL THE REMAINING OFF-LABEL USE COMPLAINTS). NO KNOWN ADVERSE EFFECTS TO THE PATIENTS.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 15-NOV-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334769 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 65 YR Male