Model Number RIC5-9W-RS PROBE |
Device Problems
Improper or Incorrect Procedure or Method (2017); Failure to Align (2522); Malposition of Device (2616)
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Patient Problems
Hemorrhage/Bleeding (1888); Perforation (2001); Excessive Tear Production (2235)
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Event Date 10/20/2016 |
Event Type
Injury
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Manufacturer Narrative
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Patient information could not be obtained due to country privacy laws.Udi not required because this is a class ii device and the date of manufacture is prior to 24-sept2016.Device returned to manufacturer and is currently under evaluation.The date of device manufacture is unavailable at time of mdr filing.Ge healthcare's investigation is ongoing.A follow up report will be submitted after the investigation has been completed.
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Event Description
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It was reported that three patients each were injured on separate dates.This report represents the third patient injury, patient (b)(6).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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Manufacturer Narrative
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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.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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Search Alerts/Recalls
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