BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 23037756 · Received September 12, 2025

    Report

    Report Number
    1037905-2025-00656
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    February 21, 2025
    Report Date
    October 7, 2025
    Manufacturer
    WILSON-COOK MEDICAL INC (COOK ENDOSCOPY)
    Product Code
    KNT
    PMA / PMN Number
    K920703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 CONCLUSION: 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. PRIOR TO DISTRIBUTION, ALL PEG PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET PUSH - PULL ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS. ADDITIONAL COMMENTS REGARDING THIS REPORT: INFORMATION ON COOK ENDOSCOPY/WILSON-COOK INC PEGS HAS BEEN REQUESTED TO BE COMMUNICATED TO THE PATIENT REGARDING THIS EVENT.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

    Description of Event or Problem · 0

    A PATIENT HAD AN UNKNOWN ENTERAL FEEDING TUBE PLACED. IT WAS REPORTED PER THE PATIENT'S SPOUSE THAT PATIENT'S FEEDING TUBE BROKE WHEN HE WAS TURNING AROUND. THE PEG TUBE WAS REPLACED WITHIN A FEW DAYS. THEY [PATIENT] HAVE BEEN ADVISED THAT A "METAL PIECE OF THIS DEVICE" REMAINS IN THE PATIENT'S STOMACH. THE ONLY DETACHABLE PORTION OF THE WILSON-COOK INC. PEG TUBE IS THE INTERNAL BOLSTER. THE INTERNAL BOLSTER IS NOT METAL. A PIECE OF DEVICE [INTERNAL BOLSTER] REMAINS IN THE PATIENT'S STOMACH. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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
    2655698 UNKNOWN TUBE, GASTROINTESTINAL (AND ACCESSORIES) KNT WILSON-COOK MEDICAL INC (COOK ENDOSCOPY)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN ENDOSCOPE MAKE AND MODEL