BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PUSH

    MDR report key: 2864327 · Received December 5, 2012

    Report

    Report Number
    1037905-2012-00664
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 9, 2012
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNT
    PMA / PMN Number
    K920703
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE PREPARATION AND PLACEMENT SECTIONS OF THE INSTRUCTIONS FOR USE STATE: REPLACEMENT IS RECOMMENDED EVERY THREE MONTHS OR AT THE DISCRETION OF THE PHYSICIAN. UPON REMOVING THE DEVICE AND ITS COMPONENTS, VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS OR BREAKS IN THE FEEDING TUBE ASSEMBLY. BRING THE INTERNAL BUMPER IN CONTACT WITH THE ABDOMINAL WALL, CAREFULLY AVOIDING EXCESS TENSION. APPLY GENTLE PRESSURE TO THE EXITING PORTION OF THE FEEDING TUBE AND REMOVE THE WIREGUIDE. PRIOR TO DISTRIBUTION, ALL ENTERAL FEEDING PRODUCTS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    A COOK FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PUSH WAS PLACED INSIDE THE PATIENT. WHEN RESCOPING THE PATIENT POST PLACEMENT, THE BUMPER WAS NOT SEEN IN THE STOMACH. IT HAD BEEN INADVERTENTLY PULLED INTO THE ABDOMINAL WALL. WHEN THE PHYSICIAN TRIED TO PULL IT OUT OF THE WALL, THE BUMPER SEPARATED FROM THE TUBE AND WAS LODGED IN THE ABDOMEN. THIS REQUIRED A MINOR BEDSIDE SURGERY TO REMOVE. THIS PATIENT HAD A PRIOR PEG AND THE SAME INCISION SITE WAS BEING USED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE ONLY ADDITIONAL PROCEDURE REQUIRED FOR THIS OCCURRENCE WAS DESCRIBED AS MINOR BEDSIDE SURGERY FOR REMOVAL OF DEVICE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PUSH KNT WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention