BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARCON COLON DECOMPRESSION SET

    MDR report key: 15879102 · Received November 29, 2022

    Report

    Report Number
    3001845648-2022-00816
    Event Type
    Malfunction
    Date Received
    November 29, 2022
    Report Date
    October 10, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K171619. DEVICE EVALUATION: THE CDSM-8.5 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 CDSM-8.5 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, IFU0102, 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. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS DETERMINED. IT IS KNOWN THAT THE DEVICE WAS USED FOR SIGMOID VOLVULUS. 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 CDSM DEVICE FOR VOLVULUS 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

    MIGRATION OF DECOMPRESSION TUBE 48 HOURS AFTER PLACEMENT. PATIENT UNDERWENT SIGMOIDOSCOPY WITH PLACEMENT OF ANOTHER DECOMPRESSION TUBE (CDSM-8.5); WHICH WAS REMOVED 24 HOURS LATER. TREATMENT WITH THE COLON DECOMPRESSION TUBE WAS CONSIDERED SUCCESSFUL AS DETERMINED BY IMAGING AND CLINICAL SYMPTOMS. PATIENT UNDERWENT SIGMOIDOSCOPY WITH PLACEMENT OF ANOTHER DECOMPRESSION TUBE (CDSM-8.5); WHICH WAS REMOVED 24 HOURS LATER. TREATMENT WITH THE COLON DECOMPRESSION TUBE WAS CONSIDERED SUCCESSFUL AS DETERMINED BY IMAGING AND CLINICAL SYMPTOMS. FINAL PMCF REPORT RECEIVED ON 10-OCT-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
    2084234 MARCON 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