BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

    MDR report key: 3894123 · Received February 5, 2014

    Report

    Report Number
    1037905-2014-00031
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    November 22, 2013
    Report Date
    January 6, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNT
    PMA / PMN Number
    K920703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDICAL FACILITY COMMUNICATED TO US THAT THE LOOP WIRE OF THE PG TUBE WAS DISPOSED. DETACHMENT OF THE LOOPED WIRE INSIDE THE PATIENT HAS BEEN ESTABLISHED AS A REPORTABLE EVENT. THIS IS CONSIDERED A FOREIGN BODY SITUATION. MEDICAL INTERVENTION VIA ENDOSCOPIC RETRIEVAL MAY BE REQUIRED. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED FOUND THAT THE LOOPED WIRE HAS SEPARATED FROM THE FEEDING TUBE. THE SECURING COMPONENT OF THE LOOPED WIRE REMAINS INSIDE THE CONNECTOR PIECE OF THE FEEDING TUBE ASSEMBLY BUT THE LOOPED WIRE IS MISSING. THE LOOPED WIRE WAS NOT RETURNED WITH THE DEVICE. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. FEEDING TUBE SEPARATION CAN OCCUR IF THE INCISION THROUGH THE SKIN IS LESS THAN 1 CM IN LENGTH OR DOES NOT COMPLETELY PENETRATE THE ABDOMINAL WALL INTO THE STOMACH. 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

    ON (B)(4) 2013 THE FOLLOWING INFORMATION WAS PROVIDED: DURING A GASTROSTOMY PROCEDURE, A COOK PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET WAS USED. THE CORD (LOOPED WIRE) ATTACHED TO THE PEG TUBE WAS BROKEN. THE PHYSICIAN MANUALLY PULLED OUT THE TUBE. THE PHYSICIAN USED ANOTHER NEW SET TO COMPLETE THE PROCEDURE. NO SECTION FO THE DEVICE DETACHED AND BECAME FREE INSIDE THE PATIENT. AT THIS TIME, THE INFORMATION DID NOT REASONABLY SUGGEST THAT THE REPORTABLE EVENT HAD OCCURRED. UPON RECEIPT OF THE PRODUCT FOR EVALUATION ON (B)(4) 2014, IT WAS DETERMINED THAT THE LOOP WIRE ATTACHED TO THE PEG TUBE (USED FOR PLACEMENT OF THE TUBE) WAS NOT INCLUDED WITH THE RETURNED DEVICE. ALTHOUGH THE INITIAL REPORT INDICATED THAT NO PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT, INFORMATION REGARDING THE MISSING SECTION WAS COMMUNICATED BACK TO THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76449 PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL KNT, TUBES, GASTOINTESTINAL (AND ACCESSORIES) KNT WILSON-COOK MEDICAL INC W3326427

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR OLYMPUS 160 SERIES EXERA ENDOSCOPE: MODEL # UNK