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Patient 1
EVALUATION SUMMARY: ONE DEVICE WAS RETURNED FOR EVALUATION. THE RETURNED PRODUCT DID NOT MEET SPECIFICATION AS RECEIVED. VISUAL INSPECTION OF THE DISPOSABLE DEVICE REVEALED THAT THE TIP OF THE WAVEGUIDE WAS BROKEN OFF. THE BROKEN PIECE WAS RETURNED. THE REPORTED CONDITION WAS NOT CONFIRMED BECAUSE THE DEVICE NEEDS TO BE IN AN ACTIVATED STATE TO DEVELOP FRACTURES. THE DEVICE STOPPED WORKING. INVESTIGATION PERSONNEL PERFORMED FUNCTIONAL TESTING ON THE RETURNED HAND PIECE USING A TEST LAB GENERATOR AND BATTERY. THE ASSEMBLED DEVICE RETURNED A GREEN LIGHT AND A WELCOME TONE, BUT IMMEDIATELY RETURNED A RED LIGHT EMITTING DIODE (LED) INDICATOR WITH AN ERROR TONE (ALARM ACTIVATION) WHEN THE DEVICE WAS ACTIVATED. THIS CHARACTERISTIC INDICATED THAT THE DEVICE WAS NOT FUNCTIONAL. THE WAVEGUIDE HAD ITS TIP MISSING. INVESTIGATION PERSONNEL CONCLUDED THAT THE TITANIUM WAVEGUIDE WAS IN USE WHEN IT CRACKED AND BROKE OFF, AND MAY HAVE COME IN CONTACT WITH ANY OF THE FOLLOWING; HEMOSTATS, CLIPS, STAPLES, RETRACTORS, ETC. DURING USE. THE INVESTIGATION IDENTIFIED THE CAUSE OF THE REPORTED EVENT TO BE USER ERROR. THE DEVICE INSTRUCTIONS FOR USE CURRENTLY CONTAIN A WARNING AGAINST CONTACT BETWEEN THE DISSECTOR TIP AND METAL OBJECTS (HEMOSTATS, CLIPS, STAPLES, RETRACTORS, ETC.) DURING ACTIVATION. CONTACT WITH METAL OBJECTS DURING USE WILL CAUSE THE ACTIVE BLADE TO CRACK AND MAY EVENTUALLY BREAK OFF. THIS ISSUE IS SPECIFIC TO ULTRASONIC DISSECTORS. THE INSTRUCTIONS FOR USE (IFU) ADVISES DEVICE USERS TO VISUALLY INSPECT ALL SYSTEM COMPONENTS FOR BREAKS, CRACKS, NICKS, OR OTHER DAMAGES PRIOR TO USE. IFU ALSO STATES: DO NOT USE DAMAGED COMPONENTS. USE OF DAMAGED COMPONENTS MAY RESULT IN INJURY TO THE PATIENT OR USER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.