BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH

    MDR report key: 11585562 · Received March 29, 2021

    Report

    Report Number
    1037905-2021-00135
    Event Type
    Injury
    Date Received
    March 29, 2021
    Date of Event
    March 4, 2021
    Report Date
    May 25, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FDX
    UDI-DI
    10827002226743
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REGARDING PMA/510(K): K192908. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE HANDLE AND THE MAJORITY OF THE CATHETER AND DRIVE WIRE WERE RETURNED AS WELL AS THE TIP OF THE DEVICE, HOWEVER THE BRUSH ITSELF WAS NOT ATTACHED TO THE DEVICE. THE DISTAL END OF THE DRIVE WIRE SHOWED EVIDENCE OF BEING CUT. THE PIN VISE OF THE DRIVE WIRE WAS PULLED OUT FROM THE HANDLE AND SHOWED BENDS/KINKS WHICH PREVENTED ACTUATION OF THE DEVICE. THE RETURNED COIL SPRING TIP IS APPROXIMATELY 17 MM LONG. THE BRUSH WIRE IS INTACT AT THE WELD JOINT ON THE DISTAL END OF THE COIL SPRING TIP BUT IS BROKEN AT THE PROXIMAL END OF THE COIL SPRING TIP. THE COIL SPRING TIP SHOWS EVIDENCE OF SOLDER AT THE PROXIMAL END. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. 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. 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. WITHOUT THE BRUSH AT THE DISTAL END OF THE DEVICE, THE JOINT BETWEEN THE BRUSH AND THE COIL SPRING TIP COULD NOT BE FULLY EVALUATED. THE BREAKAGE OF THE BRUSH WIRE AT THE PROXIMAL END OF THE COIL SPRING WOULD SUGGEST THE DEVICE EXPERIENCED EXCESSIVE FORCE PERHAPS DURING DEVICE REMOVAL. THE INSTRUCTIONS FOR USE INCLUDING THE FOLLOWING: "AFTER OBTAINING SPECIMEN, RETRACT BRUSH INTO SHEATH." FAILURE TO RETRACT THE BRUSH INTO THE SHEATH MAY CAUSE EXCESS FORCE ON THE DEVICE DURING REMOVAL FROM THE SCOPE. PRIOR TO DISTRIBUTION, ALL CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSHES 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. 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 Manufacturer Narrative · 1

    INFORMATION REGARDING PMA/510(K): K192908. 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. PRIOR TO DISTRIBUTION, ALL CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSHES 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.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH. AFTER PERFORMING THE BRUSH CYTOLOGY, THE PHYSICIAN PULLED THE DEVICE OUT FROM THE ENDOSCOPE AND FOUND THE FILIFORM TIP WAS SEPARATED AND MISSING. THE PHYSICIAN FOUND THE MISSING FILIFORM TIP IN THE DUODENUM AND REMOVED IT FROM THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED RETRIEVAL OF THE DETACHED FILIFORM TIP FROM THE DUODENUM. 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
    481166 CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH FDX ENDOSCOPIC CYTOLOGY BRUSH FDX COOK ENDOSCOPY W4403199 10827002226743

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention