BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 13258577 · Received January 14, 2022

    Report

    Report Number
    1037905-2022-00020
    Event Type
    Injury
    Date Received
    January 14, 2022
    Date of Event
    December 15, 2021
    Report Date
    January 14, 2022
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    PKL
    UDI-DI
    00827002580107
    Adverse Event
    Yes
    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

    510(K): K192697. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN 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 COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED, BECAUSE ALL THE DEVICE COMPONENTS (PARTICULARLY THE CLIP) WERE NOT INCLUDED IN THE RETURN. 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, THE DRIVE WIRE WAS OBSERVED TO MOVE FREELY INSIDE THE OUTER SHEATH. A VISUAL EXAMINATION OF THE DRIVE WIRE, CATHETER ATTACHMENT, AND COIL CATHETER (DISTAL END DEVICE COMPONENTS) SHOWED NO DEFORMITIES OR SIGNS OF DAMAGE. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OCCURRENCE WAS NOT OBSERVED. 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: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE CONDITION OF THE PRODUCT SAID TO BE INVOLVED PROHIBITED A COMPLETE EVALUATION, THE CLIP HAD BEEN DEPLOYED AND WAS NOT INCLUDED IN THE RETURN. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. A CORRECTIVE ACTION HAS BEEN INITIATED TO REDUCE OCCURRENCES OF DEPLOYMENT DIFFICULTY FOR INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTIONS. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. 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 A CLIPPING PROCEDURE, A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE WAS USED. THE CLIP WOULD NOT DETACH FROM THE POLYP AFTER DEPLOYED [DIFFICULT TO DEPLOY ONCE ATTACHED TO TISSUE]. THE CLIP WAS PULLED OFF OF THE POLYP WHICH CAUSED MORE DAMAGE AND BLEEDING. TWO OTHER CLIPS WERE USED ON THE SITE THAT WORKED SUCCESSFULLY. UPON REMOVAL OF THE DEVICE FROM THE ENDOSCOPE, THE CLIP DEPLOYED IN THE ENDOSCOPE CHANNEL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; THE CLIP ENDED UP DETACHING INSIDE SCOPE AND STAYED THERE UNTIL BRUSHING STEP OF CLEANING. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE; OTHER THAN AN ADDITIONAL CLIP BEING APPLIED DUE TO DAMAGE AND BLEEDING. 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
    682035 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL COOK ENDOSCOPY G58010 W4473537 00827002580107

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention OLYMPUS COLONOSCOPE, CF-HQ190L