BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 11746441 · Received April 29, 2021

    Report

    Report Number
    1037905-2021-00172
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 2, 2021
    Report Date
    May 20, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    PKL
    UDI-DI
    00827002580107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION/ADDITIONAL INFORMATION FOLLOW UP REPORT IS BEING SUBMITTED TO CORRECT THE DATE DEVICE RECEIVED BY MANUFACTURER. PMA/510(K) # K192697. INITIAL REPORTER OCCUPATION: COORDINATOR. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT FOR HALF OF CLIP FELL OFF. USED DEVICE: THE DEVICE WAS RETURNED IN THE CLOSED POSITION. ONE OF THE CLIP JAWS WAS MISSING, THE NITINOL STRIP IS STILL PRESENT. THE CLIP OPENS AND CLOSES DURING HANDLE MANIPULATION. THE DEVICE WAS NOT FUNCTION TESTED IN THE SCOPE DUE TO THE CONDITION OF THE RETURNED DEVICE. A VISUAL EXAMINATION OF THE DISTAL END UNDER MAGNIFICATION DID NOT IDENTIFY A ROOT CAUSE. THE CLIP JAW AND PINS HOLDING IT IN PLACE WERE NOT PRESENT OR RETURNED WITH THE DEVICE. THE REST OF THE DISTAL END COMPONENTS HAD NO ANOMALIES OR DAMAGE. OUR LABORATORY EVALUATION OF THE RETURNED SEALED DEVICE, FROM THE SAME LOT NUMBER AS THE USED DEVICE DID NOT CONFIRM THE REPORT. 10 SEALED DEVICES WERE RETURNED. 9 FROM THE LOT MENTIONED IN THE REPORT, AND 1 SEALED DEVICE FROM LOT # W4416647. 10 SEALED DEVICES- 9 SEALED DEVICES FROM LOT NUMBER W4429415: THE SAMPLES WERE VISUALLY EVALUATED PER THE SUPPLIERS SPECIFICATION TO EVALUATE THE LENGTH OF THE STYLET WIRES THAT HOLD THE CLIP JAW IN PLACE. ALL SAMPLES PASSED THE VISUAL CRITERIA. A FUNCTIONAL TEST WAS PERFORMED PER TEST PROTOCOL FOR OPEN/CLOSE AND FULL DEPLOYMENT ON SIMULATED TISSUE. THE JAWS DID NOT DETACH FROM THE CLIPS DURING OPEN/CLOSING ON THE SIMULATED TISSUE OR DURING DEPLOYMENT. THE COMPLAINT WAS NOT CONFIRMED FOR THE SEALED DEVICES. 1 SEALED DEVICE FROM LOT NUMBER W4416647: THE SAMPLE WAS VISUALLY EVALUATED PER THE SUPPLIERS SPECIFICATION TO EVALUATE THE LENGTH OF THE STYLET WIRES THAT HOLD THE CLIP JAW IN PLACE. THE SAMPLE PASSED THE VISUAL CRITERIA. A FUNCTIONAL TEST WAS PERFORMED PER TEST PROTOCOL FOR OPEN/CLOSE AND FULL DEPLOYMENT ON SIMULATED TISSUE. THE JAWS DID NOT DETACH FROM THE CLIP DURING OPEN/CLOSING ON THE SIMULATED TISSUE OR DURING DEPLOYMENT. THE COMPLAINT WAS NOT CONFIRMED FOR THE SEALED DEVICE. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. THE DEVICE HISTORY RECORD CONTAINS A NONCONFORMANCE FOR STYLET WIRE SHORT, THAT COULD POTENTIALLY BE RELATED TO JAW FALLS OFF. THE DEVICE GOES THROUGH VARIOUS INSPECTIONS PRIOR TO LEAVING THE FACILITY. THESE INSPECTIONS WOULD HAVE REMOVED ANY NONCONFORMING DEVICES PRIOR TO DISTRIBUTION. INVESTIGATION CONCLUSION: USED DEVICES: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED, ONE OF THE CLIP JAWS WAS DETACHED AND NOT RETURNED WITH THE DEVICE. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. SEALED DEVICES: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE RETURNED SEALED DEVICES FUNCTIONED AS INTENDED. PRIOR TO DISTRIBUTION, ALL INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE 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: 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 Manufacturer Narrative · 1

    PMA/510(K) # K192697. INITIAL REPORTER OCCUPATION: COORDINATOR. THE PRODUCT WAS RETURNED TO THE APPROVED SUPPLIER FOR EVALUATION AND THE INVESTIGATION IS ON-GOING. ONCE ADDITIONAL INFORMATION HAS BEEN RECEIVED A FOLLOW-UP EMDR REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, THE PHYSICIAN USED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. WHILE TRYING TO USE THE DEVICE, HALF THE CLIP FELL OFF THE DISTAL END OF THE CATHETER. ONE CLIP ARM STUCK TO THE MUCOSA AND THE OTHER CLIP ARM BROKE OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. A SECTION OF THE CLIP REMAINED IN THE PATIENT TO PASS NATURALLY. 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
    642882 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL COOK ENDOSCOPY G58010 W4429415 00827002580107

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ENDOSCOPE, GIF-H190