Model Number 989605414121 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Perforation (2001)
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Event Date 05/17/2019 |
Event Type
Injury
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Manufacturer Narrative
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A thorough inspection with functional and safety tests of the involved transducer was performed by the local philips service engineer.Proper functionality of the transducer was confirmed and the device remains at the customer site.Since a return of the transducer is not expected, no additional device analysis can be performed.
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Event Description
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A customer reported detecting a perforated esophagus after performing a transesophageal (tee) examination using an x7-2t model transducer with an epiq ultrasound system.The procedure was completed without any observed harm to the patient.The injury was noticed the next day, and the patient received treatment for the perforated esophagus.Further information regarding the patient condition post procedure was not disclosed and the device remains at the customer site.
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Search Alerts/Recalls
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