BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 2688767 · Received August 6, 2012

    Report

    Report Number
    1037905-2012-00443
    Event Type
    Malfunction
    Date Received
    August 6, 2012
    Date of Event
    July 5, 2012
    Report Date
    July 11, 2012
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K944220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: PER THE COMPLAINT, WE WERE INFORMED THAT THE BLUE HOOK HAD DETACHED FROM THE CATHETER. HOWEVER, THE LOADING CATHETER WITH BOTH BLUE HOOKS ATTACHED TO EACH CATHETER END WAS RETURNED. DURING THE VISUAL EXAMINATION, IT WAS NOTED THAT BOTH BLUE HOOKS WERE DISTORTED FROM THEIR REGULAR SHAPE AND WERE NOT FULLY SEATED INSIDE THE CATHETER. BLUE HOOK #1: IT WAS NOTICED THAT THE HOOK PORTION WAS GREATLY MISSHAPED, INDICATING A FORCE HAD BEEN APPLIED. IT WAS ALSO NOTED THAT THE CATHETER HAD A SMALL PUNCTURE HOLE SITUATED ADJACENT TO THE BLUE HOOK. THE BLUE HOOK WAS NOT FULLY SEATED IN THE CATHETER. BLUE HOOK #2: THE BLUE HOOK APPEARED DISTORTED IN THAT IT WAS SLIGHTLY BENT, AGAIN INDICATING A FORCE HAD BEEN APPLIED. THERE WAS NO INDICATION OF DAMAGE TO THE END OF THE CATHETER. THE CONDITION OF THE RETURNED PRODUCT IS INDICATIVE TO LOADING ISSUES THAT ARE TYPICALLY ENCOUNTERED WHEN THE KNOT OF THE LOADING STRING IS PLACED DIRECTLY ADJACENT TO THE BLUE HOOK. A MANUAL TUG OF EACH BLUE HOOK WAS UNDERTAKEN AND NEITHER HOOK WOULD DETACH FROM THE CATHETER. BOTH BLUE HOOKS WERE THEN DETACHED FROM THE CATHETER WITH PLIERS TO FURTHER THE INVESTIGATION. A KINK WAS IDENTIFIED ON THE LOADING CATHETER AT APPROXIMATELY 132 CM. THREE KINKS WERE IDENTIFIED ON THE STYLET WIRE AT APPROXIMATELY 9 CM, 90 CM, AND 130 CM. THE INNER DIAMETER OF THE LOADING CATHETER, THE LENGTH OF THE LOADING CATHETER, THE LENGTH OF THE LOADING CATHETER'S STYLET WIRE, AS WELL AS THE BLUE HOOKS WERE MEASURED AND VERIFIED TO BE WITHIN THE APPROPRIATE MANUFACTURING SPECIFICATIONS. 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 THE CONDITION OF THE RETURNED PRODUCT COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. CLARIFICATION WAS REQUESTED REGARDING BOTH BLUE HOOKS BEING ATTACHED TO THE CATHETER ALTHOUGH THE COMPLAINT REPORT WAS ASSOCIATED WITH BLUE HOOK DETACHMENT, BUT ADDITIONAL INFO WAS NOT RECEIVED. THE INSTRUCTIONS FOR USE DIRECT THE USER TO ATTACH THE TRIGGER CORD TO THE HOOK ON THE END OF THE LOADING CATHETER, LEAVING APPROXIMATELY 2 CM OF TRIGGER CORD BETWEEN THE KNOT AND THE HOOK. IF THE KNOT AND THE HOOK ARE PLACED CLOSER THAN 2 CM, THIS CAN CREATE RESISTANCE WHEN WITHDRAWING THE LOADING CATHETER THROUGH THE LIGATOR HANDLE AND/OR ACCESSORY CHANNEL OF THE ENDOSCOPE. IF ADDITIONAL PRESSURE IS APPLIED TO THE LOADING CATHETER WHEN RESISTANCE IS ENCOUNTERED, THIS COULD CONTRIBUTE TO SEPARATION OF THE BLUE HOOK FROM THE LOADING CATHETER. PRIOR TO DISTRIBUTION, ALL MULTI-BAND LIGATORS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD PROVIDED BY THE CUSTOMER CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS BEEN IMPLEMENTED TO REDUCE OCCURRENCES OF BLUE HOOK DETACHMENT. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTION. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    THE INITIAL INFO PROVIDED TO COOK INCLUDED: NOT POSSIBLE TO RETRIEVE THE TRIGGER CORD. THE BLUE HOOK HAD BEEN BLOCKED INSIDE THE CORD NODE. UPON RECEIPT OF THE COMPLAINT FORM, THE FOLLOWING DESCRIPTION WAS PROVIDED: WHEN THE NURSE PULLED THE CORD INSIDE THE ENDOSCOPE, THE BLUE HOOK DETACHED FROM THE CATHETER AND STAYED BLOCKED INSIDE THE ENDOSCOPE. IT IS NOT AN ISSUE WITH THE NODE, BUT AN ISSUE WITH THE BLUE HOOK WHICH FELT AND REMAINED IN THE OPERATING CHANNEL. THIS OCCURRED DURING THE LOADING PROCESS; THE LOADING CATHETER WAS NOT LOCATED INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, 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 WILSON-COOK MEDICAL INC W3104287

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS GASTROSCOPE