DEPUY SYNTHES PRODUCTS LLC HIGH SPEED ELEC G1 HANDPIECE AIR COOLED; MOTOR, DRILL, ELECTRIC - HANDPIECE
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Catalog Number EG1A |
Device Problems
Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.
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Event Description
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This is report 1 of 2 for the same event.It was reported that during an unspecified surgical procedure of the spine, it was observed that the handpiece device displayed a c-2 error code and an attachment device became stuck to the handpiece device.It was reported that there was no delay in the procedure as identical spare devices were available for use.The reporter stated that the eg1 system went through troubleshooting by resetting the system.It was reported that the system reset cleared the code and the procedure continued.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the reported condition that the device was displaying a c2 error code and had an attachment device stuck to it was confirmed.An assessment was performed and it was observed that the attachment device was attached to the handpiece and the console gave a c-2 error code when the handpiece device was plugged in.It was observed that the locking ring was moved to the unlock position and the attachment device was removed.The assignable root cause of this condition was determined to be user error.During repair the motor was found to be worn out and had an open phase b.It was determined that this condition caused the device to display the c2 error.The assignable root cause of the worn out motor was determined to be due to normal wear over time.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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