BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE

    MDR report key: 10967746 · Received December 8, 2020

    Report

    Report Number
    1037905-2020-00536
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Date of Event
    November 10, 2020
    Report Date
    January 7, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FDI
    UDI-DI
    00827002226470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED: INITIAL REPORTER; OCCUPATION: UNKNOWN. CONTINUED: PMA/510(K) # K191048. 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. 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: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING INFORMATION TO ASSIST WITH PROPER SETUP AND USE OF THE DEVICE: "FULLY RETRACT AND EXTEND THE SNARE TO CONFIRM SMOOTH OPERATION OF THE DEVICE." PRIOR TO DISTRIBUTION, ALL ACUSNARE POLYPECTOMY SNARES 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.

    Description of Event or Problem · 0

    THE FOLLOWING WAS INITIALLY REPORTED: "DURING MULTIPLE ENDOSCOPIC POLYPECTOMY PROCEDURES, THE PHYSICIAN USED MULTIPLE COOK ACUSNARE POLYPECTOMY SNARES. THE DUCK BILL SNARES WERE NOT OPENING AND CLOSING PROPERLY [SUBJECT OF REPORT] DURING THE PROCEDURE. MULTIPLE ATTEMPTS FOR THE EXACT QUANTITY WERE COMPLETED, BUT THE QUANTITY REMAINS UNKNOW." PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020 THE CUSTOMER STATED THAT SHE FEELS LIKE SHE HAS TISSUE WHEN SHE CLOSES BUT DOES NOT ACTUALLY HAVE TISSUE. IT IS NOT A SMOOTH CLOSE. SHE SAID THAT SHE FEELS LIKE THE DEVICE STILL NEEDS TO BE CLOSED AFTER IT IS CLOSED. THE CUSTOMER CONFIRMED THAT THERE WERE FIVE (5) USED COMPLAINT DEVICES. 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.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER; OCCUPATION: UNKNOWN. PMA/510(K) # K191048. 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. 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: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING INFORMATION TO ASSIST WITH PROPER SETUP AND USE OF THE DEVICE: "FULLY RETRACT AND EXTEND THE SNARE TO CONFIRM SMOOTH OPERATION OF THE DEVICE." PRIOR TO DISTRIBUTION, ALL ACUSNARE POLYPECTOMY SNARES 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 AND THIS REPRESENTS AN ISOLATED OCCURRENCE. 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 · 1

    DURING MULTIPLE ENDOSCOPIC POLYPECTOMY PROCEDURES, THE PHYSICIAN USED MULTIPLE COOK ACUSNARE POLYPECTOMY SNARES. THE DUCK BILL SNARES WERE NOT OPENING AND CLOSING PROPERLY [SUBJECT OF REPORT] DURING THE PROCEDURE. MULTIPLE ATTEMPTS FOR THE EXACT QUANTITY WERE COMPLETED, BUT THE QUANTITY REMAINS UNKNOWN. 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
    1433761 ACUSNARE POLYPECTOMY SNARE FDI, SNARE, FLEXIBLE FDI COOK ENDOSCOPY G22647 W4343222 00827002226470

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE, UNKNOWN MAKE OR MODEL| OLYMPUS CFH180AL ENDOSCOPE