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Model Number FC1SP |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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During evaluation, it was noted that broken fibers were present throughout the cable.Additionally, the cable exhibited a concentrated number of broken fibers which indicates mishandling of the cable.The concentration of broken fibers led to an elevated temperature.Invuity's ifu clearly states to handle the cables with care and not to coil the cables tighter than six (6) inches.
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Event Description
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It was reported during a hip replacement procedure, the fiber optic cable may have been placed on the drape of the patient.During use, the temperature of the fiber optic cord felt hot and left a burn mark on the drape.The case was completed without incident or product malfunction.There was no patient injury involved.
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Search Alerts/Recalls
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