Model Number 8500-0082-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Laceration(s) of Esophagus (2398)
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Event Date 06/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Return of the suspect transducer is anticipated.Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.
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Event Description
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A customer reported encountering an incident where a patient sustained an injury to their esophagus and pharynx during an angiogram using an x7-2t transducer model transducer with an ie33 ultrasound system.No medical treatment was required for the injury.The philips field service engineer has recommended a replacement of the suspect transducer.
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Manufacturer Narrative
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A thorough investigation was performed to identify the root cause of the reported issue, including a technical and clinical evaluation of this event.The engineering team determined the injury was unrelated to any product defect; the transducer passed onsite functional testing and was not returned by the customer for further analysis.The patient injury was minor and did not require any further medical intervention.The involved transducer is at the customer site with no additional similar issues reported.H3 other text: the involved transducer was kept and continues to be used by the customer.
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Event Description
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A customer reported encountering an incident where a patient sustained an injury to their esophagus and pharynx during an angiogram using an x7-2t transducer model transducer with an ie33 ultrasound system.No medical treatment was required for the injury.The philips field service engineer has recommended a replacement of the suspect transducer.
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Search Alerts/Recalls
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