BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PUSH

    MDR report key: 1993732 · Received January 13, 2011

    Report

    Report Number
    1037905-2011-00015
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 14, 2010
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNT
    PMA / PMN Number
    K920703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: WE COULD NOT CONFIRM THE REPORT BECAUSE, THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVAL. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED, WE CAN REPORT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN FINISHED GOODS INVENTORY. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. CONCLUSIONS: DURING THE PROCEDURE TO PLACE THE FEEDING TUBE, THE WIRE GUIDE INCLUDED IN THE SET IS PLACED INSIDE THE PT BEFORE ADVANCING THE FEEDING TUBE INTO POSITION. IN ORDER TO POSITION THE WIRE GUIDE, THE SNARE PROVIDED IN THE SET IS USED TO GRASP THE WIRE GUIDE AND PULL THE WIRE GUIDE INTO POSITION. UNRAVELING OF THE WIRE GUIDE CAN OCCUR IF THE SNARE IS SEVERELY TIGHTENED ONTO THE WIRE GUIDE. IF THE SNARE AND WIRE GUIDE ARE PULLED WITH THE SNARE IN THIS POSITION, THIS COULD HAVE CONTRIBUTED TO THE REPORTED WIRE GUIDE DAMAGE. WIRE GUIDE DAMAGE 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. THE INSTRUCTIONS FOR USE INSTRUCT THE USER TO MAKE A 1CM INCISION THROUGH THE SKIN AND SUBCUTANEOUS TISSUE TO FACILITATE PASSAGE OF THE FEEDING TUBE. A SMALLER OR INCOMPLETE INCISION MAY CAUSE RESISTANCE WHEN THE FEEDING TUBE IS BEING ADVANCED INTO POSITION OVER THE WIRE GUIDE. IF THE WIRE GUIDE EXPERIENCES EXCESSIVE PRESSURE DURING USE AND/OR GENERAL HANDLING, DAMAGE OF THE WIRE GUIDE CAN OCCUR. PRIOR TO DISTRIBUTION, ALL FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SETS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MFG PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. NO FURTHER ACTION WARRANTED AT THIS TIME BECAUSE, THIS REPORT COULD NOT BE VERIFIED. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING PLACEMENT OF A GASTROSTOMY TUBE, THE PHYSICIAN SELECTED A COOK ENDOSCOPY FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET. THE USER REPORTED THAT THE OUTER PORTION OF THE WIRE GUIDE BEGAN TO UNRAVEL AS THE GASTROSTOMY TUBE WAS ADVANCED OVER THE WIRE GUIDE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THIS DEVICE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADD'L MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PUSH KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES) KNT WILSON-COOK MEDICAL INC W2902239

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ENDOSCOPE (UNK MODEL NUMBER)