BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 18025889 · Received October 27, 2023

    Report

    Report Number
    1037905-2023-00520
    Event Type
    Malfunction
    Date Received
    October 27, 2023
    Date of Event
    October 4, 2023
    Report Date
    November 16, 2023
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    PKL
    UDI-DI
    00827002580107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K): K212323. THIS INVESTIGATION IS ONGOING. WE WILL SUBMIT A FOLLOW-UP EMDR WITHIN 30 DAYS OF THIS SUBMISSION.

    Additional Manufacturer Narrative · 0

    PMA/510(K): K212323 INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A GREEN FOLDER WITH AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT AS IT WAS DESCRIBED, DUE TO THE DAMAGE TO THE DEVICE. THE DEVICE WAS RETURNED WITHOUT THE CLIP. THE DEVICE WAS FUNCTIONALLY TESTED OUTSIDE OF THE SCOPE, AND THE DRIVE WIRE ADVANCED/RETRACTED WITH SLIGHT RESISTANCE. DURING FUNCTIONAL TESTING THE DEVICE WAS ADVANCED INTO THE ACCESSORY CHANNEL OF A PENTAX COLONOSCOPE (2.8 MM CHANNEL) WHICH WAS PLACED IN A SIMULATED LOWER GI POSITION. THE TIP OF THE ENDOSCOPE WAS RETROFLEXED TO SIMULATE WORST CASE SCENARIO. WITH HANDLE MANIPULATION AND WIGGLING OF THE HANDLE, THE DRIVE WIRE WAS OBSERVED TO MOVE INSIDE THE OUTER SHEATH. A VISUAL EXAMINATION OF THE DRIVE WIRE, CATHETER ATTACHMENT, AND COIL CATHETER (DISTAL END DEVICE COMPONENTS) SHOWED THAT THE DRIVE WIRE WAS BENT AND THE COIL CATH AND CATH ATTACH HAD MOVED PROXIMALLY AND WAS SIGNIFICANTLY COMPRESSED. THE COMPRESSION SUPPORTS ADDITIONAL FORCE WAS APPLIED TO THE DEVICE DURING DEPLOYMENT. A REDDISH BROWN SUBSTANCE WAS ALSO NOTED TO BE ON THE DISTAL END OF THE CLIP. 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 CONCLUSION: OUR LABORATORY EVALUATION OF THE DEVICE CONFIRMED THE COMPLAINT AS IT WAS DESCRIBED. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED.. THE INSTRUCTIONS FOR USE STATES, "NOTE: IF SEPARATION OF CLIP IS NOT IMMEDIATE, GENTLY MOVE CATHETER BACK AND FORTH OR USE OTHER ENDOSCOPIC MANEUVERS TO SEPARATE CATHETER FROM CLIP." PRIOR TO DISTRIBUTION, ALL INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING 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: 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 · 0

    DURING AN ERCP IN THE AMPULLA, THE PHYSICIAN USED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. IT WAS REPORTED THAT WHEN THE CLIP EXITED THE SCOPE EVERYTHING LOOKED FINE, [ENDOSCOPY TECH] ASKED [THE NURSE] TO ROTATE THE DEVICE AND SHE COULD NOT. THEY WERE ABLE TO GRAB TISSUE AND IT WAS DIFFICULT TO DEPLOY, BUT THE USERS WERE ABLE TO DEPLOY THE CLIP ONTO THE TARGET TISSUE WHEN THE DOCTOR PULLED THE CATHETER BACK TOWARDS THE SCOPE. A SECTION OF THE DEVICE DID NOT REMAIN 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
    1952751 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL WILSON-COOK MEDICAL INC W4750835 00827002580107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OLYMPUS TJF-190.