BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

    MDR report key: 1931621 · Received November 22, 2010

    Report

    Report Number
    1037905-2010-00650
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Report Date
    October 23, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNT
    PMA / PMN Number
    K920703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. 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. INFO REGARDING THE LENGTH OF THE INITIAL INCISION WAS REQUESTED BUT NOT PROVIDED. DIFFICULTY PULLING THE GASTROSTOMY TUBE THROUGH THE STOMACH WALL 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 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 EXITS THE INCISION SITE. INADEQUATE LUBRICATION OF THE FEEDING TUBE PRIOR TO PLACEMENT COULD CONTRIBUTE TO RESISTANCE IN TUBE PLACEMENT. THE INSTRUCTIONS FOR USE INSTRUCT THE USER TO THOROUGHLY LUBRICATE THE ENTIRE EXTERNAL LENGTH OF THE FEEDING TUBE. 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: THIS TYPE OF OCCURRENCE 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 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 ENDOSCOPY FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET. AN INCISION WAS MADE IN THE ABDOMEN. DURING PLACEMENT OF THE GASTROSTOMY TUBE, DIFFICULTY WAS ENCOUNTERED PULLING THE TUBE THROUGH THE INCISION SITE. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE 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. NO MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED. 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 COOK ENDOSCOPY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE (UNKNOWN TYPE)