BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 12002782 · Received June 15, 2021

    Report

    Report Number
    1037905-2021-00251
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    May 19, 2021
    Report Date
    July 27, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    PKL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K192697. INITIAL REPORTER OCCUPATION: UNKNOWN. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT, THE CLIP WAS NOT INCLUDED IN THE RETURN. DURING A FUNCTIONAL TEST, THE HANDLE WAS MANIPULATED, AND THE DRIVE WIRE MOVED FREELY INSIDE THE OUTER SHEATH. THE DEVICE WAS THEN ADVANCED DOWN AN OLYMPUS 2.8 MM CHANNEL ENDOSCOPE IN A SIMULATED UPPER GI POSITION WITH THE TIP IN THE MAXIMUM RETROFLEXED POSITION TO SIMULATE A WORST-CASE POSITION. WITH HANDLE MANIPULATION, THE DRIVE WIRE WAS AGAIN OBSERVED TO MOVE FREELY INSIDE THE OUTER SHEATH. A VISUAL EXAMINATION OF THE DRIVE WIRE HOOK, 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: THE CUSTOMER MENTIONED THE FOLLOWING, WHICH CONFIRMS PREDEPLOYMENT MAY HAVE OCCURRED DUE TO HOLDING THE HANDLE SPOOL: "THE CUSTOMER ADMITTED TO THE REP THAT SHE WAS NOT HOLDING THE CLIP IN THE CORRECT MANNER. SHE WAS HOLDING HER HAND IN THE THUMB RING AND SPOOL." THE INSTRUCTIONS FOR USE STATES: "WITH CLIP CLOSED AND WITHOUT HOLDING HANDLE SPOOL, ADVANCE DEVICE IN SMALL INCREMENTS INTO ACCESSORY CHANNEL OF GASTROSCOPE OR COLONOSCOPE. CAUTION: HOLDING HANDLE SPOOL DURING CLIP ADVANCEMENT MAY PREMATURELY DEPLOY CLIP." FAILURE TO FOLLOW THE INSTRUCTIONS ABOVE CAN RESULT IN DAMAGE TO THE DEVICE WHICH MAY LEAD TO PREMATURE CLIP DEPLOYMENT. HOWEVER, EVEN IF THE CLIP IS NOT DEPLOYED, DAMAGE CAN OCCUR TO INTERNAL DEVICE COMPONENTS SUCH AS THE DRIVER LEGS. ONCE THIS DAMAGE OCCURS, THE CLIP IS IN A PARTIALLY DEPLOYED STATE AND MAY NOT BE ABLE TO BE OPENED/REOPENED. PRIOR TO DISTRIBUTION, ALL INSTINCT ENDOSCOPIC HEMOCLIPS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED REMOTE. 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. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED THAT THE CLIP WAS NOT HELD IN THE CORRECT MANNER, A COOK REPRESENTATIVE HAS CONTACTED THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K192697. INITIAL REPORTER OCCUPATION: UNKNOWN. 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 DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. THE CUSTOMER MENTIONED THE FOLLOWING, WHICH CONFIRMS PREDEPLOYMENT MAY HAVE OCCURRED DUE TO HOLDING THE HANDLE SPOOL: "THE CUSTOMER ADMITTED TO THE REP THAT SHE WAS NOT HOLDING THE CLIP IN THE CORRECT MANNER. SHE WAS HOLDING HER HAND IN THE THUMB RING AND SPOOL." THE IFU STATES THE FOLLOWING PRECAUTION: "HOLDING HANDLE SPOOL DURING CLIP ADVANCEMENT MAY PREMATURELY DEPLOY CLIP." PRIOR TO DISTRIBUTION, ALL INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN UNUSUAL OCCURRENCE. 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. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED THAT THE CLIP WAS NOT HELD IN THE CORRECT MANNER, A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Description of Event or Problem · 1

    DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, THE PHYSICIAN USED TWO (2) COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES. THERE WAS DIFFICULTY WITH OPENING AND CLOSING THE CLIPS. BOTH CLIPS PREMATURELY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH A HEMOSPRAY. ADDITIONAL INFORMATION WAS PROVIDED THAT THE CLIPS PREMATURELY DEPLOYED [IN UNKNOWN POSITION] AND THE PHYSICIAN ADMITTED TO THE COOK REPRESENTATIVE THAT SHE WAS NOT HOLDING THE CLIP IN THE CORRECT MANNER. SHE WAS HOLDING HER HAND IN THE THUMB RING AND SPOOL. THE CLIPS REMAINED INSIDE THE PATIENT¿S BODY TO PASS NATURALLY. 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
    896194 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL COOK ENDOSCOPY W4302186

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OLYMPUS GASTROSCOPE, UNKNOWN MODEL.