BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR CLPLSE90 ELECTRODE W HAND CNTRLS

    MDR report key: 9158119 · Received October 4, 2019

    Report

    Report Number
    1221934-2019-58803
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    January 1, 2019
    Report Date
    September 4, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705010097
    PMA / PMN Number
    K113545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. WE RECEIVED FOUR DEVICES FOR THIS COMPLAINT. HOWEVER, THE LOT NUMBERS ARE NOT PHYSICALLY PRESENT ON EACH DEVICE. THEREFORE; WE CANNOT MATCH THE IDENTITIES BASED ON LOT NUMBER. EVALUATIONS FOR ALL FOUR COMPLAINT DEVICES RECEIVED WILL BE DOCUMENTED IN THIS PRODUCT INVESTIGATION. DEVICE 1: VISUAL INSPECTION REVEALS THAT ACTIVE TIP LOOKS IN USED CONDITION. SINCE,THE LOT NUMBERS ARE PHYSICALLY NOT PRESENT ON THE DEVICE. HENCE,THIS DEVICE IS REFERRED TO (B)(4). THIS COMPLAINT CAN BE CONFIRMED. NO VISIBLE SALINE RESIDUE IN SUCTION TUBE. THE DEVICE WAS FORWARDED TO MANUFACTURER FOR FURTHER EVALUATION OF THE DEVICE. THE MANUFACTURER INDICATED THAT THE DEVICE PASSED ALL ELECTRICAL TESTS AND FLOW RATE WAS FAILED IN FUNCTIONAL TEST. SEVERAL ATTEMPTS WERE MADE TO UNBLOCK THE DEVICE, BY ACTIVATING THE DEVICE IN SALINE, WHILST APPLYING A POSITIVE AND NEGATIVE PRESSURE TO THE SUCTION TUBE. THIS DID NOT INCREASE THE FLOW. THE DEVICE HANDLE WAS OPENED AND INSPECTED FOR ANY ANOMALIES OR BLOCKAGES WITHIN THE VISIBLE SUCTION PATH. INSPECTION RESULTED IN NO CLEAR AND OBVIOUS BLOCKAGE / RESTRICTION. A WIRE WAS FED UP THE SUCTION PATH TOWARDS THE DISTAL END; THE RESTRICTION WAS LOCATED AT THE PROXIMAL APPROX. 2MM INSIDE THE ACTIVE SUCTION TUBE. THE BLOCKAGE IS BELIEVED TO BE CAUSED BY GLUE, ATTEMPTS TO REMOVE THE GLUE WITH A WIRE WERE UNSUCCESSFUL. THIS WOULD EXPLAIN WHY THERE WAS VISIBLE SALINE RESIDUE IN THE SUCTION TUBE. FURTHER INVESTIGATION INTO THIS FAILURE MODE IS BEING CONDUCTED UNDER CAP- 101588. THIS INVESTIGATION HAS SHOWN THAT DUE TO THE DEVICE DESIGN, THERE IS POTENTIAL FOR THE UV GLUE TO MIGRATE INTO THE SUCTION PATH DUE TO THE GLUE NOT BEING CURED SUFFICIENTLY TO PREVENT MOVEMENT INTO THE SUCTION PATH. THE UNINTENTIONAL CURING OF THE DISPLACED UV GLUE WAS THEN FULLY ACHIEVED WITH EXPOSURE TO RADIATION DURING THE STERILIZING PROCESS. A REVIEW OF OUR COMPLAINT RECORDS OVER THE LAST 12 MONTHS TO ASSESS THE FREQUENCY OF THIS DEFECT FOR THE CP90 PRODUCT CODE 22847 SHOWS TWO FAILURES IN (B)(4) SALES THEREFORE THE FREQUENCY OF OCCURRENCE IS (B)(4) AND THE OCCURRENCE IS AS EXPECTED IN RA DOCUMENT. DOCUMENT. PREVIOUS FAILURE (B)(4) RECEIVED IN DECEMBER 2018. DEVICE 2:VISUAL INSPECTION REVEALS THAT ACTIVE TIP LOOKS IN USED CONDITION. NO VISIBLE SALINE RESIDUE IN SUCTION TUBE. SINCE,THE LOT NUMBERS ARE PHYSICALLY NOT PRESENT ON THE DEVICE. HENCE,THIS DEVICE IS REFERRED TO (B)(4). THE DEVICE WAS FORWARDED TO MANUFACTURER FOR FURTHER EVALUATION OF THE DEVICE. THE MANUFACTURER INDICATED THAT THE DEVICE PASSED ALL ELECTRICAL TESTS AND FLOW RATE WAS FAILED IN FUNCTIONAL TEST. SEVERAL ATTEMPTS WERE MADE TO UNBLOCK THE DEVICE, BY ACTIVATING THE DEVICE IN SALINE, WHILST APPLYING A POSITIVE AND NEGATIVE PRESSURE TO THE SUCTION TUBE. THIS DID NOT INCREASE THE FLOW. THE DEVICE HANDLE WAS OPENED AND INSPECTED FOR ANY ANOMALIES OR BLOCKAGES WITHIN THE VISIBLE SUCTION PATH. INSPECTION RESULTED IN NO CLEAR AND OBVIOUS BLOCKAGE / RESTRICTION. A WIRE WAS FED UP THE SUCTION PATH TOWARDS THE DISTAL END; THE RESTRICTION WAS LOCATED AT THE DISTAL END AT THE ACTIVE TIP. THE BLOCKAGE IS CAUSED BY TISSUE BUILD UP AT THE TIP, WHICH COULD BE SEEN UNDER MAGNIFICATION. IT WAS NOT FOUND POSSIBLE TO REMOVE THE BUILD UP TO FREE THE BLOCKAGE. THE LIKELY CAUSE OF THE REPORTED SUCTION BLOCKAGE TO BE NORMAL PROCEDURAL DEBRIS (SEEN UNDER MAGNIFICATION) WITHIN THE ACTIVE TIP. THE PRODUCT IFU CAUTIONS NOT TO ALLOW THE ELECTRODE TO BECOME COVERED IN TISSUE DEBRIS. IF THIS OCCURS, USE A NEW ELECTRODE. THE COMPLAINT FAILURE MODE HAS BEEN REVIEWED AGAINST THE SYSTEMS RISK ASSESSMENT DOCUMENT (B)(4) WHICH HAS RECORDED IN LINE 242.41 'POOR SUCTION FLOW THROUGH DEVICE DUE TO TISSUE BLOCKAGE' CAUSED BY TISSUE ENTERING THE TIP AND LEADING TO A BLOCKAGE. A REVIEW OF OUR COMPLAINT RECORDS OVER THE LAST 12 MONTHS TO ASSESS THE FREQUENCY OF THIS DEFECT AND ANALYSIS SHOWS THAT THE FREQUENCY OF THIS OCCURRENCE IS AS ANTICIPATED IN RISK MANAGEMENT (B)(4). DEVICE 3:VISUAL INSPECTION REVEALS THAT ACTIVE TIP LOOKS IN USED CONDITION. SINCE,THE LOT NUMBERS ARE PHYSICALLY NOT PRESENT ON THE DEVICE. HENCE,THIS DEVICE IS REFERRED TO (B)(4). THE ACTIVE TIP IS IN A USED CONDITION, WITH TISSUE VISIBLE IN THE ACTIVE TIP SUCTION PORT. SALINE RESIDUE VISIBLE IN SUCTION TUBE. THE PLUG OF THE DEVICE HAS BEEN CUT OFF. THE DEVICE WAS FORWARDED TO MANUFACTURER FOR FURTHER EVALUATION OF THE DEVICE. THE MANUFACTURER INDICATED THAT THE TESTING NOT PERFORMED DUE TO PLUG BEING REMOVED FROM CABLE. FUNCTIONAL TESTING LIMITED TO FLOW TESTING ONLY DUE TO PLUG BEING REMOVED FROM CABLE. DEVICE 4: VISUAL INSPECTION REVEALS THAT ACTIVE TIP LOOKS IN USED CONDITION. THE ACTIVE TIP IS IN A USED CONDITION, SALINE RESIDUE VISIBLE IN SUCTION TUBE. SINCE,THE LOT NUMBERS ARE PHYSICALLY NOT PRESENT ON THE DEVICE. HENCE,THIS DEVICE IS REFERRED TO (B)(4). THE PLUG OF THE DEVICE HAS BEEN CUT OFF. THE MANUFACTURER INDICATED THAT THE TESTING NOT PERFORMED DUE TO PLUG BEING REMOVED FROM CABLE. FUNCTIONAL TESTING LIMITED TO FLOW TESTING ONLY DUE TO PLUG BEING REMOVED FROM CABLE. HENCE, UNABLE TO REPRODUCE THE CUSTOMER REPORTED SUCTION DEFECT AS THE DEVICE WAS FOUND TO PASS FLOW RATE TESTING AND MEET THE MANUFACTURERS SPECIFICATION. THE COMPLAINT REFERRED TO THREE CP90 DEVICES BLOCKING DURING USE. FOUR CP90 DEVICES WERE ACTUALLY RETURNED FOR INVESTIGATION. THE FLOW TEST ESTABLISHED THAT TWO OF THE DEVICES FAILED TO MEET THE REQUIRED SPECIFICATION AND TWO MET THE SPECIFICATION. FURTHER INVESTIGATION INTO THE FAILURES FOUND THE RESTRICTION IN FLOW WAS RESULTANT OF TISSUE BUILD UP AT THE DISTAL END ON THE ONE DEVICE AND UV GLUE ENTERING THE PROXIMAL END OF THE ACTIVATE SUCTION TUBE. NEITHER OF THE BLOCKAGES COULD BE REMOVED AFTER SEVERAL ATTEMPTS. HENCE, UNABLE TO REPRODUCE THE CUSTOMER REPORTED SUCTION DEFECT AS THE DEVICE WAS FOUND TO PASS FLOW RATE TESTING AND MEET THE MANUFACTURERS SPECIFICATION. FOR DEVICE 1 - UV GLUE BLOCKAGE. INTRODUCED CHANGE TO ASSEMBLY AID ¿ (B)(4), TO INCLUDE THE FOLLOWING STATEMENT: ¿IF THERE IS A DELAY TO THE NORMAL OPERATING PROCESS TIME, ANY SUB-ASSEMBLIES IN THE UV GLUE OR UV CURE STATIONS MUST BE REMOVED AND SCRAPPED. THIS IS REQUIRED AS THE SUB-ASSEMBLIES MAY NOT BE FULLY PROCESSED AND MAY ALLOW UNCURED UV GLUE TO MIGRATE INTO THE SUCTION TUBE CAUSING A SUCTION BLOCKAGE.¿ DOCUMENT (B)(4) UPDATED AND NEW REVISION (ET) IMPLEMENTED ON (B)(4). ADDED A STATEMENT TO INDYSOFT FOR (B)(4) (LINEAR LINE 1) AND (B)(4) (LINEAR LINE 2): ¿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

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: UPDATED DATA: D10 (CONCOMITANT MEDICAL PRODUCTS). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT: (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI:(B)(4).

    Description of Event or Problem · 1

    THESE 3 ELECTRODES CLOGGED RIGHT AFTER THEY STARTED TO USE THEM THE SURGEON HAS USED THIS TYPE OF INSTRUMENT FOR A FEW YEARS WITHOUT PROBLEMS. THE SURGEON SOLVED THE SITUATION WITH SIMILAR PRODUCT. 3 PIECES IN A ROW: 228147 VAPR COOLPULSE ELECTRODE, 2 PIECES WITH LOT U1901192, 1 PIECE WITH LOT U1901093. EVENT DATE: DURING THE SUMMER. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED THE ELECTRODES WERE USED IN 3 SEPARATE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952190 VAPR CLPLSE90 ELECTRODE W HAND CNTRLS ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE GEI DEPUY MITEK LLC US U1901192 10886705010097

    Patients

    Seq Age Sex Outcome Treatment
    1