BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 2033618 · Received February 11, 2011

    Report

    Report Number
    1037905-2011-00059
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K944220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 FOR EVAL. 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 WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS REMOTE. 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. INFO PROVIDED WITH THIS REPORT INDICATES THE 6 SHOOTER SAEED MULTI-BAND LIGATOR WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION ON A PT WITH BARRETT'S ESOPHAGUS. THE INTENDED USE LISTED IN THE 6 SHOOTER SAEED MULTI-BAND LIGATOR INSTRUCTIONS FOR USE STATES "THIS DEVICE IS USED TO ENDOSCOPICALLY LIGATE ESOPHAGEAL VARICES AT OR ABOVE THE GASTROESOPHAGEAL JUNCTION OR TO LIGATE INTERNAL HEMORRHOIDS." THE INSTRUCTIONS FOR USE DIRECT THE USER NOT TO USE THIS DEVICE FOR ANY PURPOSE OTHER THAN THE STATED INTENDED USE. THE INSTRUCTIONS FOR USE DIRECT THE USER TO PLACE THE ENDOSCOPE TIP IN A STRAIGHT POSITION DURING THE LOADING PROCESS. LOADING THE BARREL AND TRIGGER CORD WITH THE ENDOSCOPE TIP CURVED CAN CONTRIBUTE TO PREMATURE BAND DEPLOYMENT. PREMATURE BAND DEPLOYMENT CAN OCCUR IF CARE IS NOT EXERCISED WHILE LOADING THE DEVICE ONTO THE ENDOSCOPE. THE INSTRUCTIONS FOR USE DIRECT THE USER TO SLOWLY ROTATE THE HANDLE CLOCKWISE TO WIND THE TRIGGER CORD ONTO THE HANDLE SPOOL UNTIL IT IS TAUT. THE INSTRUCTIONS ADVISE THE USER THAT CARE MUST BE TAKEN TO AVOID PREMATURE BAND DEPLOYMENT WHEN WINDING THE TRIGGER DURING SYSTEM PREPARATION. PREMATURE BAND DEPLOYMENT CAN ALSO OCCUR IF THE HANDLE IS PLACED IN THE FIRING POSITION BEFORE THE ENDOSCOPE IS IN PLACE INSIDE THE PT. THE INSTRUCTIONS FOR USE DIRECT THE USER TO KEEP THE HANDLE IN THE TWO-WAY POSITION PRIOR TO INTRODUCING THE ENDOSCOPE. AFTER INTUBATION, THE INSTRUCTIONS FOR USE DIRECT THE USER TO PLACE THE HANDLE IN THE FIRING POSITION. RAPID ROTATION OF THE LIGATOR HANDLE CAN CONTRIBUTE TO PREMATURE BAND DEPLOYMENT. THE INSTRUCTIONS FOR USE DIRECT THE USER TO MAINTAIN SUCTION AND DEPLOY THE BAND BY ROTATING THE HANDLE CLOCKWISE UNTIL BAND RELEASE IS FELT. DURING THE PROCEDURE, ENDOSCOPIC SUCTION IS APPLIED TO THE BANDING SITE TO PROPERLY PLACE A LIGATOR BAND. PREMATURE BAND DEPLOYMENT CAN ALSO OCCUR IF THE HANDLE IS ROTATED BEFORE MAINTAINING SUCTION ON THE BANDING SITE. THE INSTRUCTIONS FOR USE ADVISE THE USER TO MAINTAIN SUCTION WHILE DEPLOYING THE BAND. IF THE LIGATOR HANDLE IS IN THE FIRING POSITION WHILE THE ENDOSCOPE IS STRAIGHTENED, THIS CAN RESULT IN PREMATURE BAND DEPLOYMENT DUE TO TENSION ON THE TRIGGER CORD. THE INSTRUCTIONS FOR USE DIRECT THE USER TO PLACE THE HANDLE IN THE TWO-WAY POSITION BEFORE STRAIGHTENING THE ENDOSCOPE. THE INSTRUCTIONS FOR USE DIRECT THE USER TO REMOVE THE ENDOSCOPE AND ATTACH A NEW LIGATOR IF MORE BANDS ARE REQUIRED. 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 MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS BEEN IMPLEMENTED IN AN EFFORT TO REDUCE OCCURRENCES OF PREMATURE BAND DEPLOYMENT. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR), THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. WHEN THE PHYSICIAN DEPLOYED THE 5TH BAND FROM THE LIGATOR BARREL, THE 6TH BAND DEPLOYED AS WELL. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADD'L 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 WILSON-COOK MEDICAL INC W2949868

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR OLYMPUS GASTROSCOPE (UNK MODEL NUMBER)