BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3005075853-2019-17113

    MDR report key: 8405705 · Received March 8, 2019

    Report

    Report Number
    3005075853-2019-17113
    Event Type
    Malfunction
    Date Received
    March 8, 2019
    Date of Event
    January 16, 2019
    Report Date
    February 26, 2019
    PMA / PMN Number
    K120729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # P9247W. INVESTIGATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE TISSUE PAD DETACHED AND NOT RETURNED BUT WITH EVIDENCE OF BODY FLUIDS AND TISSUE PAD MATERIAL IN THE GROOVE SECTION OF THE CLAMP ARM. THE DEVICE WAS CONNECTED TO A TEST HAND PIECE AND A GEN11; DURING FUNCTIONAL TESTING IT WAS NOTED THAT THE HAND ACTIVATION BUTTONS WERE NONFUNCTIONAL. HOWEVER, THE DEVICE DID ACTIVATE WHEN TESTED WITH THE FOOT SWITCH. THE DEVICE WAS ANALYZED, AND IT WAS DETERMINED THAT IT WAS CONNECTED IN MORE THAN ONE GENERATOR. THE DEVICE IS INTENDED AND LABELED FOR SINGLE PATIENT USE. IF THE DEVICE IS CONNECTED TO MULTIPLE GENERATORS AN ALERT SCREEN WILL BE DISPLAYED INDICATING ¿ADAPTIVE TISSUE TECHNOLOGY FEATURES ARE NOT AVAILABLE IN THIS DEVICE¿. THE DEVICE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS. CORROSION WAS FOUND AT THE HAND ACTIVATION DOMES. BASED ON THE CONDITION OF THE TISSUE PAD, A PROBABLE CAUSE FOR THIS DAMAGE IS THAT THE CLAMP OF THE DEVICE MAY HAVE BEEN CLOSED AND THE INSTRUMENT ACTIVATED WITHOUT TISSUE PRESENT. CARE SHOULD BE TAKEN NOT TO APPLY PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. KEEP THE CLAMP ARM OPEN WHEN BACK CUTTING OR WHILE THE BLADE IS ACTIVE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO AVOID DAMAGE TO THE TISSUE PAD. THE RESULTING DAMAGE CONTRIBUTES TO THE REMOVAL OF THE PAD FROM THE CLAMP ARM. THE CLEANING OF THE PAD, NOT IN ACCORDANCE WITH THE IFU, CAN ALSO RESULT IN REMOVAL OF THE PAD DURING USE. THIS DEVICE IS PACKAGED AND STERILIZED FOR SINGLE USE ONLY. MULTIPLE PATIENT USE MAY COMPROMISE THE DEVICE INTEGRITY OR CREATE A RISK OF CONTAMINATION THAT, IN TURN, MAY RESULT IN PATIENT INJURY OR ILLNESS. DUE TO THE MOISTURE DISCOVERED ON THE INSTRUMENT WHICH IS EVIDENCE OF POSSIBLE REUSE, WE ARE UNABLE TO DETERMINE HOW THIS CONDITION IMPACTED THE PERFORMANCE OF THE DEVICE AND THEREFORE CANNOT CONCLUDE ROOT CAUSE. OUR MANUFACTURING, STERILIZATION, PACKAGING, AND SHIPMENT PROCESSES DO NOT INTRODUCE CORROSION / MOISTURE TO THE DEVICE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # P9247W. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE WHITE TISSUE PAD HAD FALLEN OFF. THE FALLEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISPOSED OF. CHANGED TO ANOTHER ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE