BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

    MDR report key: 2092720 · Received May 5, 2011

    Report

    Report Number
    1037905-2011-00266
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 6, 2011
    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
    PHYSICIAN

    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. 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. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN 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: 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. 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 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 FEEDING TUBE, THE PHYSICIAN USED A COOK FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL. THE PT HAD PREVIOUS OPEN HEART SURGERY THEREFORE, EXCESSIVE SCAR TISSUE WAS PRESENT IN THE ABDOMEN WHERE THE FEEDING TUBE WAS TO BE PLACED. A 1CM INCISION WAS MADE IN THE PT'S ABDOMEN TO PREPARE FOR PLACEMENT OF THE FEEDING TUBE. THE PHYSICIAN ATTEMPTED TO PULL THE TAPERED END OF THE FEEDING TUBE THROUGH THE INCISION; HOWEVER, THE TUBE WAS UNABLE TO BE PULLED THROUGH. THE PHYSICIAN MADE TWO ADD'L INCISIONS IN AN ATTEMPT TO WIDEN THE INCISION SITE BUT TUBE PLACEMENT WAS UNSUCCESSFUL. THE PROCEDURE WAS ABORTED. THE PT WAS SENT FOR SURGICAL PLACEMENT OF THE FEEDING TUBE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. 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. W2954338

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE (UNK TYPE)