It was reported that three patients each were injured on separate dates.This report represents the second patient injury, patient b.The ric5-9w-rs ultrasound probe, along with a voluson p6, biopsy needle ebt 00230s-0 (elios bio tek), and a biopsy guide of unknown type were being used to assist an ovarian biopsy for harvesting oocytes when the ovary was punctured and/or torn with the biopsy needle.Surgery, celiography, was required in order to stop the internal bleeding.The user reported that the virtual guide for the needle was offset and therefore needle placement was incorrect.
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Updated with manufacture dates.Probe serial # (b)(4) date of manufacture is 13-may2014 and probe serial (b)(4) date of manufacture is 01-apr2015.Updated with results of investigation.The probes were replaced to correct this issue, ges investigation has concluded and the results are as follows: both probes had been mechanically damaged (dropped) prior to use, and the 3d scan head could not properly calibrate causing the "virtual guide" to be offset.The user was able to detect the damage via a failed calibration message, and the user decided to continue to operate/use the damaged probes.Therefore the injuries were due to continued use of a damaged & malfunctioning probe despite being warned of the malfunction.Further analysis of malfunction complaint data and design documentation indicates the probability of reoccurrence is remote.
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