Model Number 1565161 |
Device Problems
Mechanical Problem (1384); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device was checked and it was identified that the moon clip was wore causing the groove it sits in to ramp and let the bracket move down a bit.The bracket and clip were replaced and device functioned as designed.Further investigation should confirm the root cause.Investigation results will be provided within a final report if new information will become available.
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Event Description
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It is alleged that the display monitor bracket was dropping down slightly.No harm or significant impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint (b)(4).
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Manufacturer Narrative
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The iled light system was inspected by a field service technician.It was identified that the locking segment (crescent key) wore causing the groove it sits in to ramp and let the bracket move down a bit.Based on our product history records no preventive maintenance is noted.The device is 8 years old and preventative maintenance is required every 2 years.Regarding the maintenance protocol the moon clip needs to be checked and the thickness should be measured.The root cause for the event was traced to not following the instructions for use, missing regularly preventive maintenance.The light system was repaired and checked for functionality.Based on this, no further actions are required.
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Event Description
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It was alleged that the display monitor bracket was dropping down slightly.No harm or significant impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint #(b)(4).
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Search Alerts/Recalls
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