BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

    MDR report key: 2043476 · Received February 25, 2011

    Report

    Report Number
    1037905-2011-00097
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Report Date
    January 26, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNT
    PMA / PMN Number
    K920703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: A PRODUCT EVAL WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVAL. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD AND SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDERING AND SHIPPING HISTORY, THE LOT NUMBER INVOLVED COULD NOT BE DETERMINED. 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. 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 GASTROSTOMY TUBE EXITS THE INCISION SITE. INADEQUATE LUBRICATION OF THE FEEDING TUBE PRIOR TO PLACEMENT COULD CONTRIBUTE TO DIFFICULTY PASSING THE GASTROSTOMY TUBE THROUGH THE INCISION SITE AND SUBSEQUENT TUBE SEPARATION. THE INSTRUCTION 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. CORRECTIVE ACTION: THIS TYPE OF OCCURRENCE HAS BEEN BROUGHT TO THE ATTENTION OF THE APPROPRIATE INTERNAL PERSONNEL IN AN EFFORT TO HEIGHTEN AWARENESS. NO FURTHER ACTION WAS TAKEN AT THIS TIME. 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 PLACEMENT OF A GASTROSTOMY TUBE, THE PHYSICIAN USED A COOK FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL. THE PHYSICIAN INDICATED THE TRANSITION ON THE GASTROSTOMY TUBE DID NOT MOVE THROUGH THE INCISION SITE SMOOTHLY, CREATING RESISTANCE DURING PLACEMENT. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITH THIS DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT 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 - PULL KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES) KNT WILSON-COOK MEDICAL INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS 160 SERIES ENDOSCOPE (UNK MODEL #)