BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 4172842 · Received October 9, 2014

    Report

    Report Number
    1037905-2014-00398
    Event Type
    Injury
    Date Received
    October 9, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 12, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    MND
    PMA / PMN Number
    K944220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE RECOMMENDED SCOPE SIZE FOR THIS PRODUCT INDICATED THAT THIS PRODUCT IS RECOMMENDED FOR ENDOSCOPES HAVING A DISTAL END DIAMETER OF 9.5 MM - 13.0 MM. THE USER INDICATED THAT THIS PRODUCT WAS USED WITH A PENTAX EC-2990I ENDOSCOPE WHICH HAS AN INSERTION TUBE DIAMETER OF 9.8MM AND IS THEREFORE COMPATIBLE WITH THIS PRODUCT. A PRODUCT SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. THE SUB ASSEMBLY WORK ORDER FOR THE FRICTION FIT ADAPTER WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. 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. INVESTIGATION CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE ALL OF THE DEVICE COMPONENTS (PARTICULARLY THE BARREL) WERE NOT RETURNED. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF A DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. LABELING ON THE DEVICE LISTS THE RECOMMENDED ENDOSCOPE SIZE FOR EACH MULTI-BAND LIGATOR. USE OF THE PRODUCT WITH AN ENDOSCOPE TOO LARGE OR TOO SMALL CAN RESULT IN THE BARREL BECOMING DISLODGED. THE CAUTION LABEL ON THE DEVICE INSTRUCTS THE USER TO "ENSURE BARREL IS FULLY ADVANCED ONTO TIP OF ENDOSCOPE. FAILURE TO DO SO MAY RESULT IN BARREL BECOMING DISLODGED". THE INSTRUCTIONS FOR USE DIRECT THE USER TO LUBRICATE THE ENDOSCOPE AND EXTERIOR PORTION OF THE BARREL. THE BARREL CAN DISLODGE IF LUBRICANT IS APPLIED TO THE ENDOSCOPE PRIOR TO ATTACHING THE BARREL OR IF LUBRICANT IS ALLOWED INSIDE THE BARREL BEFORE THE LOADING PROCESS. THE INSTRUCTIONS FOR USE CAUTION THE USER NOT TO PLACEMENT LUBRICANT INSIDE THE BARREL. 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 THIS LOT MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING AN ESOPHAGEAL VARICES LIGATION PROCEDURE, A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR WAS USED. AFTER LIGATION OF THE THIRD VARICES, TWO ELASTIC [BANDS] WERE LOST [PREMATURELY DEPLOYED] DUE TO BAD MANIPULATION. SEE MDR 1037905-2014-00399. THE DOCTOR PULLED UP THE ENDOSCOPE AND THE BARRIER [BARREL] WAS NO LONGER ON THE GASTROSCOPE. THE BARREL HAD SLIPPED INTO THE STOMACH AND WAS QUICKLY RECOVERED WITH A FOREIGN BODY FORCEPS. SEE MDR 1037905-2014-00398. THERE IS NO PROBLEM NOW. THE DETACHED BARREL WAS REMOVED FROM THE PATIENT WITH FOREIGN BODY FORCEPS. SEE MDR 1037905-2014-00398. OTHER THAN THE BANDS THAT PREMATURELY DEPLOYED, SEE MDR 1037905-2014-00399, NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45451 6 SHOOTER SAEED MULTI-BAND LIGATOR LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC. W3412585

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention