BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUDI NAV SUCTION, 90 - 1PK

    MDR report key: 8462459 · Received March 28, 2019

    Report

    Report Number
    3005172759-2019-00119
    Event Type
    Malfunction
    Date Received
    March 28, 2019
    Date of Event
    March 4, 2019
    Report Date
    March 5, 2019
    Manufacturer
    ACCLARENT, INC.
    Product Code
    PGW
    UDI-DI
    10705031245891
    PMA / PMN Number
    K180948
    Removal / Correction Number
    03182019-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THIS MDR REPORT IS TO CORRECT THE MANUFACTURE¿S REFERENCE NUMBER. ON THE INITIAL REPORT, IT WAS INCORRECTLY DOCUMENTED AS (B)(4). THE CORRECT MANUFACTURE REFERENCE NUMBER IS MANUFACTURER¿S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR IS TO CORRECT THE MANUFACTURE INFORMATION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. THE DEVICE DOES NOT HAVE AN EXPIRATION DATE AS IT IS A NON-STERILE RE-USABLE DEVICE. [CONCLUSION]: ON (B)(4) 2019 ACCLARENT IDENTIFIED 3 LOTS OF TRUDI¿ NAV SUCTION INSTRUMENTS (0°, 70° & 90°) THAT WERE DISTRIBUTED TO CUSTOMERS HAD A CALIBRATION ISSUE IN ONE OF THEIR COMPONENTS. THIS CALIBRATION ISSUE CAUSED AN INCORRECT TIP ORIENTATION DISPLAY IN THE TRUDI¿ SYSTEM THAT IS USED IN CONJUNCTION WITH THE DEVICE. THE SURGEON STILL HAS A FUNCTIONING ENDOSCOPIC VIEW IN ADDITION TO THE LOCATION FEATURE OF THE TRUDI¿ SYSTEM. NO ADVERSE EVENTS HAVE BEEN REPORTED FOR THIS INCIDENT. ON (B)(4) 2019 ACCLARENT INITIATED A REMOVAL OF THESE LOTS IN THE FIELD FOR THE POTENTIAL SAFETY RISK ASSOCIATED WITH THE INCORRECT TIP ORIENTATION DISPLAY. THE 90-DEGREE TRUDI NAVIGATION SUCTION DEVICE (TDNS090Z / 1901219) ASSOCIATED WITH THIS COMPLAINT IS FROM ONE OF THE THREE LOTS IDENTIFIED WITH THE CALIBRATION ISSUE IN ONE OF THE COMPONENTS. THE CALIBRATION ISSUE WAS NOT NOTICED DURING THE CASE, A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE ON (B)(6) 2019; THE ISSUE WAS VERIFIED THE FOLLOWING DAY ON (B)(6) 2019, AFTER TESTING THE SUCTION FUNCTION ON THE SYSTEM. THE PRODUCT WAS RETURNED AS PART OF THE AFFECTED LOT UNDER A STOP SHIPMENT NOTIFICATION. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT. INVESTIGATION SUMMARY: THE 90-DEGREE TRUDI NAVIGATION SUCTION DEVICE WAS RECEIVED ON MARCH 18, 2019. BEFORE DECONTAMINATION, THE RETURNED DEVICE UNDERWENT VISUAL INSPECTION AND WAS OBSERVED TO HAVE NO OBVIOUS DAMAGE. THE DEVICE UNDERWENT DECONTAMINATION FOR TWO HOURS WITH A 10% BLEACH SOLUTION. THE RETURNED DEVICE UNDERWENT ELECTRICAL TESTING USING THE LAB MULTIMETER (CALIBRATION DATE: 2/1/2019; DUE 2/29/2020. BELOW ARE THE RESULTS OF THE ELECTRICAL TESTING: KNOB POSITION PURPOSE PASS CRITERIA RESULTS: SENSOR-SENSOR CONNECTIVITY 200 O ±25 O (202.3O), 2 CONNECTIVITY OF SHIELD TO DEVICE STAINLESS STEEL BODY < 10 O (1.3 O), 3 EEPROM CONNECTIVITY > 50 KO AND < 10MO (5.889 KO), 4 ISOLATION BETWEEN SENSOR AND SHIELD > 1 MO (0L MO), 5 ISOLATION BETWEEN SENSOR AND EEPROM IO > 1 MO (0L MO), 6 ISOLATION BETWEEN SENSOR AND EEPROM GND > 1 MO (0L MO), 7 ISOLATION BETWEEN SHIELD AND EEPROM IO > 1 MO (0L MO), 8 ISOLATION BETWEEN SHIELD AND EEPROM GND > 1 MO (0L MO). THE ELECTRICAL TEST RESULTS UNDERWENT FURTHER REVIEW WAS PERFORMED ON MARCH 25, 2019. IT WAS IDENTIFIED THAT IT IS POSSIBLE TO OBTAIN A FALSE FAILURE READING ON KNOB 3. AS A RESULT, THE ELECTRICAL TESTING WAS UPDATED TO ADD A NOTE TO ALLOW FOR THE TESTING TO BE REPEATED IN OPPOSITE SEQUENCE IN THE EVENT OF HAVING A VALUE THAT DOES NOT MEET THE PASS CRITERIA FOR THE EEPROM CONNECTIVITY TEST. THIS WAS TO ALIGN WITH THE TEST METHOD CURRENTLY IMPLEMENTED DURING MANUFACTURING AND AT VIANT MEDICAL. ELECTRICAL TESTING WAS PERFORMED ON THE RETURNED DEVICE AGAIN ON MARCH 27, 2019 USING THE LAB MULTIMETER (CALIBRATION DATE: 2/1/2019; DUE 2/29/2020. BELOW ARE THE RESULTS OF THE ELECTRICAL TESTING: KNOB POSITION PURPOSE PASS CRITERIA RESULTS: SENSOR-SENSOR CONNECTIVITY 200 O ±25 O (202.3O), 2 CONNECTIVITY OF SHIELD TO DEVICE STAINLESS STEEL BODY < 10 O (1.3 O), 3 EEPROM CONNECTIVITY > 50 KO AND < 10MO (411.4 KO), 4 ISOLATION BETWEEN SENSOR AND SHIELD > 1 MO (0L MO), 5 ISOLATION BETWEEN SENSOR AND EEPROM IO > 1 MO (0L MO), 6 ISOLATION BETWEEN SENSOR AND EEPROM GND > 1 MO (0L MO), 7 ISOLATION BETWEEN SHIELD AND EEPROM IO > 1 MO (0L MO), 8 ISOLATION BETWEEN SHIELD AND EEPROM GND > 1 MO (0L MO). THE RETURNED COMPLAINT DEVICE WAS CONFIRMED TO MEET TESTING SPECIFICATION / REQUIREMENTS. THE RETURNED COMPLAINT DEVICE WAS PLUGGED INTO A TRUDI¿ UNIT (KT-2004-00F, SF VERSION (B)(4)) AND THE FOLLOWING WAS OBSERVED: INCORRECT TIP ORIENTATION DISPLAY IN THE TRUDI¿ SYSTEM. THE LOT HISTORY RECORD (LHR) WAS REVIEWED FOR THIS LOT (1901219). THERE WERE NO ANOMALIES FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE LHR REVIEW VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE ISSUE CALIBRATION ISSUE WAS CONFIRMED / VERIFIED WITH THE ANALYSIS TESTING PERFORMED ON THE RETURNED COMPLAINT DEVICE. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) HAS BEEN INITIATED TO DOCUMENT INVESTIGATION INTO THE ROOT CAUSE AND ALL CORRECTIVE / PREVENTATIVE ACTIONS TAKEN. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    ON (B)(4) 2019 ACCLARENT IDENTIFIED 3 LOTS OF TRUDI¿ NAV SUCTION INSTRUMENTS (0°, 70° & 90°) THAT WERE DISTRIBUTED TO CUSTOMERS HAD A CALIBRATION ISSUE IN ONE OF THEIR COMPONENTS. THIS CALIBRATION ISSUE CAUSED AN INCORRECT TIP ORIENTATION DISPLAY IN THE TRUDI¿ SYSTEM THAT IS USED IN CONJUNCTION WITH THE DEVICE. THE SURGEON STILL HAS A FUNCTIONING ENDOSCOPIC VIEW IN ADDITION TO THE LOCATION FEATURE OF THE TRUDI¿ SYSTEM. NO ADVERSE EVENTS HAVE BEEN REPORTED FOR THIS INCIDENT. ON (B)(4) 2019 ACCLARENT INITIATED A REMOVAL OF THESE LOTS IN THE FIELD FOR THE POTENTIAL SAFETY RISK ASSOCIATED WITH THE INCORRECT TIP ORIENTATION DISPLAY. THE 90-DEGREE TRUDI NAVIGATION SUCTION DEVICE (TDNS090Z / 1901219) ASSOCIATED WITH THIS COMPLAINT IS FROM ONE OF THE THREE LOTS IDENTIFIED WITH THE CALIBRATION ISSUE IN ONE OF THE COMPONENTS. THE CALIBRATION ISSUE WAS NOT NOTICED DURING THE CASE, A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE ON (B)(6) 2019; THE ISSUE WAS VERIFIED THE FOLLOWING DAY ON (B)(6) 2019, AFTER TESTING THE SUCTION FUNCTION ON THE SYSTEM. THE PRODUCT WAS RETURNED AS PART OF THE AFFECTED LOT UNDER A STOP SHIPMENT NOTIFICATION. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254001 TRUDI NAV SUCTION, 90 - 1PK TRUDI NAV SUCTION, 90 PGW ACCLARENT, INC. 1901219 10705031245891

    Patients

    Seq Age Sex Outcome Treatment
    1