BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 1133128 · Received August 22, 2008

    Report

    Report Number
    1037905-2008-00110
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 24, 2008
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FHN
    PMA / PMN Number
    K944220/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: WE WERE UNABLE TO CONFIRM THE REPORT AS IT WAS DESCRIBED BECAUSE THE AFFECTED PRODUCT WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVAL. THE USER RETURNED THREE UNUSED DEVICES FOR EVAL, TWO OF WHICH ARE FROM THE LOT NUMBER LISTED. THESE DEVICES ARE LABELED APPROPRIATELY. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR ANALYSIS OF THE UNUSED PRODUCT. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER, WE CAN REPORT THAT 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 OCCURRENCE IS REMOTE. CONCLUSION: INFO PROVIDED INDICATED THE ENDOSCOPE USED WITH THE PRODUCT IS NOT COMPATIBLE. THIS IS THE REASON FOR THE REPORTED BARREL SEPARATION. THE LABEL ON THE MBL-6 INDICATES THE ENDOSCOPE OUTER DIAMETER COMPATIBLE WITH THIS DEVICE IS 9.5MM - 13MM. THE INSTRUCTIONS FOR USE DIRECT THE USER TO REFER TO THE PACKAGE LABEL FOR ENDOSCOPE SIZE REQUIRED FOR THIS DEVICE. THE COORDINATION OF ENDOSCOPE SIZE WITH COMPATIBLE DEVICES IS ESSENTIAL IN OBTAINING OPTIMAL RESULTS DURING A PROCEDURE. ALTHOUGH THE GLOBAL PART NUMBER (GPN) LISTED IN THE PRODUCT CATALOG WAS CORRECT, AND THIS CONTRIBUTED TO THE CUSTOMER RECEIVING A MBL-6 (9.5MM-13MM) INSTEAD OF A MBL-U-6 (8.6MM-11.3MM), THE PRODUCT LABEL ON THE MBL-6 CONTAINS THE APPROPRIATE INFO TO ASSES APPROPRIATE ENDOSCOPE COMPATIBILITY. PRIOR TO DISTRIBUTION, ALL 6 SHOOTER SAEED MULTI-BAND LIGATORS ARE SUBJECTED TO A VISUAL INSPECTION PRIOR TO DISTRIBUTION. THE VISUAL INSPECTION INCLUDES VERIFICATION OF THE APPROPRIATE LABELS. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: 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 CORRECTION IS WARRANTED AT THIS TIME. THE APPROPRIATE PERSONNEL HAVE BEEN INFORMED OF THE PRODUCT CATALOG ERROR IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. NO FURTHER ACTION IS WARRANTED AT THIS TIME BECAUSE THIS REPORT WAS UNABLE TO BE VERIFIED. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    THE USER FACILITY ORDERED COOK ENDOSCOPY 6 SHOOTER SAEED MULTI-BAND LIGATORS (MBL-U-6) DEVICES USING THE GLOBAL PART NUMBER (GPN) FROM THE PRODUCT CATALOG. BECAUSE THE GPN IN THE PRODUCT CATALOG IS INCORRECT, THE CUSTOMER RECEIVED A COOK ENDOSCOPY 6 SHOOTER SAEED MULTI-BAND LIGATOR (MBL-6). DURING AN ENDOSCOPIC BANDING PROCEDURE TO TREAT ESOPHAGEAL VARICES, THE PHYSICIAN USED ONE OF THE COOK ENDOSCOPY 6 SHOOTER SAEED MULTI-BAND LIGATORS DESCRIBED ABOVE (MBL-6). THE USER DID NOT INSPECT THE LABEL FOR THE MINIMUM ENDOSCOPE DIAMETER PRIOR TO LOADING THE DEVICE ONTO THE ENDOSCOPE AND DID NOT OBSERVE THAT THE DEVICE THEY WERE PREPARING TO USE WAS NOT A MBL-U-6. THE BANDS DEPLOYED APPROPRIATELY DURING THE PROCEDURE. UPON COMPLETION OF THE BANDING, THE LIGATOR BARREL DETACHED FROM THE ENDOSCOPE INTO THE PT. THE BARREL WAS RETRIEVED ENDOSCOPICALLY. 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 6 SHOOTER SAEED MULTI-BAND LIGATOR FHN, LIGATOR, HEMORRHOIDAL FHN COOK ENDOSCOPY W2500258

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention