Model Number TL410US |
Device Problem
Fracture (1260)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 12/19/2023 |
Event Type
Injury
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Manufacturer Narrative
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The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
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Event Description
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It was reported that before a case on dec-19-2023, an employee was cut handling the device (the front of the device was broken).There was no patient involvement, and no further information was provided about the injury of the employee.
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Manufacturer Narrative
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Per investigation by the manufacturing site: no technical root cause can be evaluated.The product works as designed and described in the ifu.The most probable root cause: it is assumed, that the unit was strongly impacted from outside, which led to the front glass shattering.The sharp edges of the broken/shattered glass lead to the hurt/ cut of the operator's hand.This event is filed under internal complaint id (b)(4).
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Search Alerts/Recalls
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