BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON SELECT W/RESERVOIR G123

    MDR report key: 16477573 · Received March 3, 2023

    Report

    Report Number
    2424472-2023-00010
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Report Date
    March 14, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    PMA / PMN Number
    K970123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP REPORT IS FOR MISSED CODES FOR: MEDICAL DEVICE PROBLEM CODE : 1437. TYPE OF INVESTIGATION : 10. INVESTIGATION FINDINGS : 180 + 140. INVESTIGATION CONCLUSIONS : 4307. 03/02/23-REPAIR TECH: GPB. 03/02/23-QA: LR. EDH DSP/IF/IC/SCAN BOARD DAMAGEDINTERFACE BOARD WAS BURNT AND WAS NOT ABLE TO CONNECT THE G123 PUMP. THE COVER ITSELF ON THE G124 UNIT WHERE THE HANDPIECE IS SUPPOSED TO BE CRADLE IS BURNT. THE STERI-MATE WAS BURNT WHEN IT WAS LAYING IN THE CRADLE OF THE G124 UNIT. DEBRIS WAS BUILT UP IN THE WATER FILTER. ON THE G123 PUMP THE INTERFACE PCB ASSEMBLY WAS BURNT AND DAMAGED ALSO LEADING TO A BURNT PUMP INTERFACE. THE GROMMET BUMPER WAS BURNT AND REPLACED WITH A NEW ONE. ALL TESTING ON THE G124 UNIT AND THE G123 PUMP HAS BEEN CALIBRATED AND TESTED TO MANUFACTURE SPECS. REPLACED DAMAGED/WORN COMPONENTS AND RECALIBRATED UNIT TO FACTORY SPECS. DHR REVIEW IS NOT REQUIRED BECAUSE THE PRODUCT WAS RETURNED FOR EVALUATION AND THE CUSTOMER COMPLAINT IS A KNOWN HAZARD. CUSTOMER COMPLAINT IS A KNOWN HAZARD AND IS TRACKED AS PART OF MONTHLY PSC MEETINGS.

    Additional Manufacturer Narrative · 0

    SINCE AN OVERHEATING INSERT COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, THIS MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. INVESTIGATION RESULTS: WITHIN WARRANTY? NO. WITHIN USEFUL LIFE? NO. NOTES: (B)(6) 2023-REPAIR TECH: GPB. (B)(6) 2023 QA: LR. EDH DSP/IF/IC/SCAN BOARD DAMAGED INTERFACE BOARD WAS BURNT AND WAS NOT ABLE TO CONNECT THE G123 PUMP. THE COVER ITSELF ON THE G124 UNIT WHERE THE HANDPIECE IS SUPPOSED TO BE CRADLE IS BURNT. THE STERI-MATE WAS BURNT WHEN IT WAS LAYING IN THE CRADLE OF THE G124 UNIT. DEBRIS WAS BUILT UP IN THE WATER FILTER. ON THE G123 PUMP THE INTERFACE PCB ASSEMBLY WAS BURNT AND DAMAGED ALSO LEADING TO A BURNT PUMP INTERFACE. THE GROMMET BUMPER WAS BURNT AND REPLACED WITH A NEW ONE. ALL TESTING ON THE G124 UNIT AND THE G123 PUMP HAS BEEN CALIBRATED AND TESTED TO MANUFACTURE SPECS. REPLACED DAMAGED/WORN COMPONENTS AND RECALIBRATED UNIT TO FACTORY SPECS. DHR REVIEW IS NOT REQUIRED BECAUSE THE PRODUCT WAS RETURNED FOR EVALUATION AND THE CUSTOMER COMPLAINT IS A KNOWN HAZARD. CUSTOMER COMPLAINT IS A KNOWN HAZARD AND IS TRACKED AS PART OF MONTHLY PSC MEETINGS.

    Description of Event or Problem · 0

    WHILE G123 CAVITRON SELECT W/RESERVOIR IN FOR REPAIR EVIDENCE FOUND OF OVERHEATING AND DEBRIS BUILT UP IN WATER FILTER CAUSING ISSUE WITH WATER FLOW. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946567 CAVITRON SELECT W/RESERVOIR G123 SCALER, ULTRASONIC ELC DENTSPLY LLC G123

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown