BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLON DECOMPRESSION SET

    MDR report key: 13706025 · Received March 9, 2022

    Report

    Report Number
    3001845648-2022-00123
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Date of Event
    February 9, 2022
    Report Date
    October 10, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FEG
    UDI-DI
    00827002221819
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE
    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: 1 X CDSG-14-175 DEVICE OF LOT NUMBER C1862939 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. DOCUMENT REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION CDSG-14-175 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR CDSG-14-175 OF LOT NUMBER C1862939 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1862939. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: ¿IF PACKAGE IS OPENED OR DAMAGED WHEN RECEIVED, DO NOT USE. VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE.¿ ROOT CAUSE REVIEW: A DEFINITE ROOT CAUSE CANNOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED TO CIRL FOR EVALUATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO EXCESSIVE FORCE USED WHEN WITHDRAWING THE CATHETER FROM THE DRAINAGE TUBE WHICH CONTRIBUTED TO THE BREAKAGE THAT OCCURRED. SUMMARY: COMPLAINT IS BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, THERE WERE NO ADDITIONAL PROCEDURES REQUIRED OR ADVERSE EFFECTS TO THE PATIENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    COLON DECOMPRESSION TUBE WAS PLACED IN COLON. UPON TRYING TO WITHDRAWAL INNER GUIDING CATHETER FROM OUTER DRAINAGE TUBE, RESISTANCE WAS FELT AND THE INNER GUIDING CATHETER BROKE IN TWO PIECES. ONE PIECE OF BROKEN INNER GUIDING CATHETER CAME OUT OF THE OUTER DRAINAGE TUBE, WHILE THE OTHER PIECE WAS STUCK INSIDE THE DISTAL END OF THE OUTER DRAINAGE TUBE. COLON DECOMPRESSION TUBE, WITH BROKEN PIECE OF INNER GUIDING CATHETER, WAS THEN REMOVED FROM PATIENT. TO FINISH THE PROCEDURE, A NEW DEVICE OF THE SAME TYPE WAS PLACED AND NO OTHER ISSUES WERE ENCOUNTERED. I RECOMMENDED CUSTOMER DISASSEMBLE COLON DECOMPRESSION SET AND FLUSH AND LIBERALLY LUBRICATE EACH PIECE AND THEN REASSEMBLE BEFORE PLACEMENT. I ALSO RECOMMENDED USING A SHAKING MOTION WHEN WITHDRAWING INNER GUIDING CATHETER. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. IF YES, PLEASE DESCRIBE. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. ADDITIONAL INFORMATION PROVIDED BY DM ON 14FEB2022: " IS ANY PATIENT INFORMATION (AGE, WEIGHT, GENDER, PRE-EXISTING CONDITIONS, ANATOMICAL CHARACTERISTICS, ETC.) AVAILABLE? NOT AVAILABLE WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. WAS THE DEVICE FLUSHED BEFORE USE? YES. WHAT WAS FLUSHED THROUGH THE DEVICE (WATER, SALINE, ETC.)? WATER. WAS LUBRICATION APPLIED TO THE DECOMPRESSION TUBE? YES. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? USED WIRE GUIDE SUPPLIED WITH DECOMPRESSION TUBE. PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. COLON HOW EXPERIENCED WAS THE PHYSICIAN WITH USING THE CDSG? EXPERIENCED WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? SAME PROCEDURE WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? NO. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? OLYMPUS 190. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DECOMPRESSION TUBE INTO POSITION? UNKNOWN. IF RESISTANCE WAS ENCOUNTERED, WAS THE ENDOSCOPE WITHDRAWN A SHORT DISTANCE? UNKNOWN. HOW OFTEN WAS THE DECOMPRESSION TUBE IRRIGATED? UNKNOWN. HOW LONG WAS THE SET LEFT IN DWELLING? N/A"--DID 15FEB2022. FOR ALL COMPLAINTS, ASK: WAS THE DEVICE FLUSHED BEFORE USE? N/A, YES, NO WHAT WAS FLUSHED THROUGH THE DEVICE (WATER, SALINE, ETC.)? N/A, WATER, SALINE, OTHER IF OTHER PLEASE SPECIFY. WAS LUBRICATION APPLIED TO THE DECOMPRESSION TUBE? N/A YES, NO. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. HOW EXPERIENCED WAS THE PHYSICIAN WITH USING THE CDSG? DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? N/A, YES, NO. WHAT INTERVENTION (IF ANY) WAS REQUIRED? WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? N/A, SAME PROCEDURE, ANOTHER DAY WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? N/A, YES, NO. IF YES, PLEASE SPECIFY WHAT WAS OBSERVED AND WHERE ON THE DEVICE IT WAS OBSERVED. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DECOMPRESSION TUBE INTO POSITION? N/A, YES, NO. IF RESISTANCE WAS ENCOUNTERED, WAS THE ENDOSCOPE WITHDRAWN A SHORT DISTANCE? N/A, YES, NO. HOW OFTEN WAS THE DECOMPRESSION TUBE IRRIGATED? DID ANY SECTION OF THE DEVICE DETACH INSIDE THE ENDOSCOPE OR PATIENT? N/A, YES, NO. HOW LONG WAS THE SET LEFT IN DWELLING?

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2759414 COLON DECOMPRESSION SET FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION FEG COOK IRELAND LTD G22181 C1862939 00827002221819

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown