BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR COOLPULSE90 ELECTRODE

    MDR report key: 10422767 · Received August 18, 2020

    Report

    Report Number
    1221934-2020-02260
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    August 5, 2020
    Report Date
    August 6, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705010080
    PMA / PMN Number
    K113545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT DURING THE SURGERY OF ACL RECONSTRUCTION, WHEN INSERT INTO THE PATIENT, NOTED THE DEVICE WAS RUSTY (227504), OPENED ANOTHER TWO DEVICES (228146), ALSO NOTED THIS ISSUE. CHANGE OTHER LOT PRODUCT TO COMPLETE THE SURGERY. THE HOSPITAL REJECT TO USE THESE LOTS. ALSO, IT WAS REPORTED TOO THAT THE HOSPITAL FACED WITH DEVICE RUSTY ISSUE AND REJECT TO USE THIS LOT (U1902171). THE DISTRIBUTOR SAMPLED 3 PIECES IN THE WAREHOUSE RANDOMLY (228146), ALL WITH THE RUSTY ISSUE AS THE PHOTOS SHOWED. THE JUAREZ LABORATORY RECEIVED 8 ELECTRODES AND THEY WERE SENT TO GYRUS FOR FURTHER INVESTIGATION DUE TO THE PRE-INVESTIGATION REVEALED THAT THE ACTIVE TIP WAS DISCOLORED IN ALL. CHINA CONFIRMED THAT THEY SENT THE REST OF THE LOT WITH 105 PCS IN TOTAL, THE ELECTRODES WERE UNUSED AND RETURNED IN ITS ORIGINAL PACKAGING; THE REMAINED DEVICES ARRIVED LABORATORY AND A SAMPLE OF 6 DEVICES WAS INSPECTED AND REVEALED THE SAME DISCOLORATION IN THE TIP. SUPPLIER SUMMARY: TO DETERMINE ROOT CAUSE AND IDENTIFY ANY CORRECTIVE ACTIONS A CAPA INVESTIGATION (B)(4) WAS CREATED AND A NON-CONFORMITY (NR-0152406) WAS INITIATED TO SUPPLIER EVALUATED THE COMPLAINT PRODUCT. THE INVESTIGATION OF A CUSTOMER COMPLAINT INVOLVING BROWN DISCOLORATION OF GYRUS ELECTRODES DETERMINED THAT THE ANOMALOUS ELECTRODE APPEARANCE IS CAUSED BY A SMALL AMOUNT OF EPOTEK 353ND RESIN DEPOSITED ON THE METAL ELECTRODE SURFACE DURING THE ACTIVATION TEST WHICH IS PERFORMED FOR EACH HANDPIECE AS PART OF END OF LINE TESTING. AN ESCALATION PROCESS WAS INITIATED UNDER PIE1890649 TO CONDUCT BOUNDING AND RISK ASSESSMENT; THEREFORE, THE BIOCOMPATIBILITY TESTING ON PURE EPOTEK RESIN HAS BEEN PERFORMED AND INDICATES THAT NO ADVERSE EFFECTS WOULD BE EXPECTED FROM DIRECT EXPOSURE TO THIS MATERIAL DURING SURGERY. IN ADDITION, THE GYRUS ELECTRODE DESIGN INCORPORATES AN AUTOMATIC SALINE CIRCULATION SYSTEM THAT EFFECTIVELY SUCTIONS AWAY OVER 98% OF ANY MATERIAL RELEASED FROM THE ELECTRODE SURFACE DURING CLINICAL USE, PREVENTING PATIENT EXPOSURE TO LEVELS ABOVE A SMALL FRACTION OF A MILLIGRAM. HENCE, IT MAY BE CONCLUDED THAT THE ELECTRODE DISCOLORATION WHICH IS RELATED TO RESIDUES OF EPOTEK 353ND WILL HAVE NO IMPACT ON PATIENT SAFETY, GIVEN THE DEMONSTRATED BIOCOMPATIBILITY OF CURED EPOTEK RESIN. AS PART OF ¿JUSTIFICATION FOR BIOCOMPATIBILITY OF MITEK ELECTRODES¿ CONFIRMING ALL MATERIALS AND SUBSTANCES USED IN THE PRODUCTION OF THE ELECTRODE ARE BIOCOMPATIBLE. IN CONCLUSION, THE DISCOLORATION ON THE PRODUCT CAN BE CONFIRMED AND DOESN'T REPRESENT A DEVIATION FROM THE APPROVED MANUFACTURING PROCESS. (SEE ATTACHMENT "NR-0152406 TOXICOLOGY MEMO_FINAL_CLEAN_SIGNED.PDF"). THE MANUFACTURER WILL EVALUATE CORRECTIVE ACTIONS TO ELIMINATE THIS COSMETIC CHARACTERISTIC. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [U1911009] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AT THIS POINT IN TIME, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [U1911009] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. D10, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. 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). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: (B)(6). UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY OF ACL RECONSTRUCTION, WHEN INSERT INTO THE PATIENT, NOTED THE DEVICE WAS RUSTY, OPENED THE ANOTHER TWO DEVICE, ALSO NOTED THIS ISSUE. CHANGE OTHER LOT PRODUCT TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL REJECT TO USE THESE LOTS. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886864 VAPR COOLPULSE90 ELECTRODE ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE GEI DEPUY MITEK LLC US 228146 U1911009 10886705010080

    Patients

    Seq Age Sex Outcome Treatment
    1