Model Number KN100110 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Perforation of Esophagus (2399)
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Event Date 04/02/2018 |
Event Type
Injury
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Manufacturer Narrative
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Udi not required.The 6vt-d probe was not returned to ge healthcare for repair.The probe was given to a third party and therefore ge is unable to evaluate the probe further.
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Event Description
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Ge healthcare received a copy of a medwatch report from a user facility where in was described patient underwent a tee in a cath lab and post-procedure the physician noted the 6vt-d probe was broken.The report alleges that the probe would steer past 90 degrees.The report says the patient developed black tarry stools and the egd was performed and the physician found in the distal esophagus a rather large tear, approximately 2.5 cm/2/5 cm at the ge junction with a large adherent clot and small amount of oozing.The area was injected with epinephrine, and the clot was slowly removed under suction.Three resolution endo clips were used to approximate the edges of the tear over these two areas as well as closing the proximal end of the tear.Patient required blood transfusion, three units given.
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Manufacturer Narrative
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Ge's investigation has completed.Multiple attempts to collect additional information were made and the customer has declined to provide further information.Therefore the actual root cause could not be found due to the lack of information supplied by the customer.Ge has concluded there is not enough data to support that the patient injury was caused by a probe malfunction, and the most likely cause of the injury was either a result of the insertion, excessive manipulation associated with imaging, or during the removal of the probe after the tee procedure.
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Search Alerts/Recalls
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