BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

    MDR report key: 1982766 · Received January 6, 2011

    Report

    Report Number
    1037905-2011-00006
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 3, 2010
    Report Date
    December 7, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNT
    PMA / PMN Number
    K920703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. THE CUSTOMER RETURNED FOUR UNUSED DEVICES FROM THE LOT NUMBER PROVIDED IN THE REPORT AS PART OF THE COMPLAINT INVESTIGATION. A DIMENSIONAL VERIFICATION OF EACH TUBE WAS CONDUCTED AND ALL DEVICES MET THE APPLICABLE SPECIFICATION. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED DURING EVAL OF THE UNUSED PRODUCT. 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. 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: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL AND THE UNUSED PRODUCT PASSED DIMENSIONAL VERIFICATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. WE REQUESTED INFO RELATED TO THE LENGTH OF THE INCISION MADE IN THE ABDOMEN, BUT THIS INFO COULD NOT BE PROVIDED. DIFFICULTY PASSING THE GASTROSTOMY TUBE THROUGH THE INCISION SITE CAN OCCUR IF THE INCISION THROUGH THE SKIN IS LESS THAN 1CM IN LENGTH OR DOES NOT COMPLETELY PENETRATE THE ABDOMINAL WALL INTO THE STOMACH. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT INSTRUCT THE USER TO MAKE A 1CM INCISION TO FACILITATE PASSAGE OF THE FEEDING TUBE. A SMALLER OR INCOMPLETE INCISION MAY CAUSE RESISTANCE WHEN THE GASTRONOMY TUBE EXITS THE INCISION SITE. INADEQUATE LUBRICATION OF THE FEEDING TUBE PRIOR TO PLACEMENT COULD CONTRIBUTE TO DIFFICULTY PASSING THE GASTRONOMY TUBE THROUGH THE INCISION SITE AND SUBSEQUENT TUBE SEPARATION. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT LINE INSTRUCTS THE USER TO LUBRICATE THE TUBE THOROUGHLY AND OVER THE ENTIRE LENGTH. THIS ACTIVITY WILL AID IN SMOOTH FEEDING TUBE PLACEMENT. 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 MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: THE REPORT OF DIFFICULTY WITH FEEDING TUBE PLACEMENT HAS BEEN BROUGHT TO THE ATTENTION OF THE APPROPRIATE INTERNAL PERSONNEL IN AN EFFORT TO HEIGHTEN AWARENESS. NO FURTHER ACTION WARRANTED AT THIS TIME BECAUSE THIS REPORT COULD NOT BE VERIFIED. THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. 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 FEEDING TUBE PLACEMENT, THE PHYSICIAN USED A COOK ENDOSCOPY FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET. DIFFICULTY WAS ENCOUNTERED PULLING THE FEEDING TUBE THROUGH THE INCISION SITE IN THE ABDOMEN. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADDITIONAL 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 - PULL KNT, GASTROINTESTINAL (AND ACCESSORIES) KNT COOK ENDOSCOPY W2901586

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE (UNKNOWN TYPE)