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Model Number DYND44180 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/08/2023 |
Event Type
Injury
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Manufacturer Narrative
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According to the facility on (b)(6) 2023 "a cytology specimen from an endoscopy lab leaked making the specimen unusable and the patient had to be brought back the next day for a repeat procedure".Per the facility there was no physical damage to the device, and the device was confirmed to be closed securely.No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
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Event Description
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According to the facility on (b)(6) 2023 "a cytology specimen from an endoscopy lab leaked making the specimen unusable and the patient had to be brought back the next day for a repeat procedure".
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Search Alerts/Recalls
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