BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 1962676 · Received January 12, 2011

    Report

    Report Number
    1037905-2011-00013
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    November 30, 2010
    Report Date
    December 13, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    MND
    PMA / PMN Number
    K944220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED TO US BY THE COOK FACILITY IN (B)(4) ON BEHALF OF A MEDICAL FACILITY IN (B)(4). (B)(6). 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. CONCLUSIONS: IF THE BARREL IS NOT ADVANCED AS FAR AS IT WILL GO ONTO THE TIP OF THE ENDOSCOPE, BARREL DETACHMENT CAN OCCUR. THE INSTRUCTIONS FOR USE ADVISE THE USER TO ENSURE THE BARREL IS ADVANCED AS FAR AS POSSIBLE ONTO THE TIP OF THE ENDOSCOPE. THE INSTRUCTIONS FOR USE DIRECT THE USER TO LUBRICATE THE ENDOSCOPE AND EXTERIOR PORTION OF THE BARREL. BARREL DETACHMENT CAN OCCUR IF LUBRICANT IS ALLOWED INSIDE THE BARREL BEFORE THE LOADING PROCESS. THE INSTRUCTIONS FOR USE CAUTION THE USER NOT TO PLACE LUBRICANT INSIDE THE BARREL. A POSSIBLE CONTRIBUTING FACTOR TO BARREL DETACHMENT INCLUDES ALLOWING BODY FLUIDS TO ENTER THE AREA BETWEEN THE BARREL AND ENDOSCOPE. THE INSTRUCTIONS FOR USE RECOMMEND PERFORMING A ROUTINE ENDOSCOPIC EXAMINATION TO CONFIRM THE DIAGNOSIS REQUIRING TREATMENT OF ESOPHAGEAL VARICES PRIOR TO LOADING THE LIGATOR ASSEMBLY. IF THE ENDOSCOPE IS WIPED FREE AFTER THE INITIAL CHECK FOR LOCATION OF THE VARICES, BODY FLUIDS IN THIS AREA CAN BE AVOIDED. THE MATERIAL USED IN THIS DEVICE HAS A SHELF LIFE OF ONE YEAR. THE MANUFACTURE DATE AND EXPIRATION DATE ARE PRINTED ON THE PRODUCT LABEL. THE EXPIRATION DATE FOR THIS PRODUCT WAS (B)(6) 2010. THE INFO PROVIDED INDICATES THE DEVICE WAS USED AFTER THE EXPIRATION DATE. PRIOR TO DISTRIBUTION, ALL 6-SHOOTER SAEED MULTI-BAND LIGATORS 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: AS CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. 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 BANDING OF ESOPHAGEAL VARICES, THE PHYSICIAN USED A COOK ENDOSCOPY 6 SHOOTER SAEED MULTI-BAND LIGATOR. THE LIGATOR BARREL SEPARATED FROM THE ENDOSCOPE AND DETACHED IN THE PT'S STOMACH. THE LIGATOR BARREL WAS RETRIEVED FROM THE PT WITH GRASPING FORCEPS. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE LENGTH OF THE PROCEDURE WAS EXTENDED DUE TO RETRIEVAL OF THE LIGATOR BARREL; HOWEVER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND COOK ENDOSCOPY W2786088

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FUJINON ENDOSCOPE (UNK MODEL NUMBER)