BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 1211205 · Received October 20, 2008

    Report

    Report Number
    1037905-2008-00145
    Event Type
    Injury
    Date Received
    October 20, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 25, 2008
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    MND
    PMA / PMN Number
    K944220/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: WE WERE UNABLE TO CONFIRM THE REPORT AS IT WAS DESCRIBED BECAUSE THE AFFECTED PRODUCT WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVALUATION. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER, WE CAN REPORT THAT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE THE DEVICES WERE PREVIOUSLY DISTRIBUTED. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS PERCENTAGE, THE LIKELIHOOD OF THIS TYPE OF REPORT IS REMOTE. CONCLUSION: WE WERE UNABLE TO CONDUCT A FULL INVESTIGATION BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION WAS UNABLE TO BE DETERMINED. BARREL DETACHMENT CAN OCCUR IF LUBRICANT IS ALLOWED INSIDE THE BARREL. THE INSTRUCTIONS FOR USE DIRECT THE USER TO LUBRICATE THE ENDOSCOPE AND EXTERIOR PORTION OF THE BARREL. THE INSTRUCTIONS FOR USE ALSO CAUTION THE USER NOT TO PLACE LUBRICANT INSIDE THE BARREL. A POSSIBLE CONTRIBUTING FACTOR TO THIS EVENT INCLUDES ALLOWING BODY FLUIDS TO ENTER THE AREA BETWEEN THE BARREL AND ENDOSCOPE. PRIOR TO ASSEMBLING THE MULTI-BAND LIGATOR, ROUTINE ENDOSCOPIC EXAMINATION IS RECOMMENDED TO CONFIRM THE DIAGNOSIS REQUIRING TREATMENT OF ESOPHAGEAL VARICES. IF THE ENDOSCOPE IS WIPED FREE AFTER THE INITIAL CHECK FOR LOCATION OF THE VARICES, BODY FLUIDS IN THIS AREA CAN BE AVOIDED. IT IS POSSIBLE BODY FLUIDS AND/OR LUBRICATION REMAINED ON THE ENDOSCOPE DURING THE LOADING PROCESS, DECREASING FRICTION BETWEEN THE BARREL AND ENDOSCOPE CONTRIBUTING TO THE REPORTED EVENT. IF THE BARREL IS NOT ADVANCED AS FAR AS POSSIBLE ONTO 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 ENDOSCOPE. PRIOR TO DISTRIBUTION, ALL MULTI-BAND LIGATORS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THIS REPORT WAS UNABLE TO BE VERIFIED. 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 CALCULATION, NO FURTHER ACTION IS WARRANTED AT THIS TIME. 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

    DURING AN ESOPHAGEAL BANDING PROCEDURE, THE PHYSICIAN USED A COOK ENDOSCOPY SIX SHOOTER SAEED MULTI-BRAND LIGATOR. ALL SIX-BANDS DEPLOYED SUCCESSFULLY. AFTER THE LAST BAND DEPLOYED, THE LIGATION BARREL DETACHED FROM THE ENDOSCOPE AND WAS LOCATED IN THE PT'S STOMACH. THE BARREL WAS RETRIEVED FROM THE STOMACH USING A DILATION BALLOON. 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 MND, LIGATOR, ESOPHAGEAL MND COOK ENDOSCOPY W2449448

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention