Model Number CRW FRAME ADAPTOR |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/27/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted.Unique identifier (udi) #: (b)(4).
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Event Description
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The company representative reported the need for a new crw frame adaptor.They have to provide extra effort in order to slot the crw frame into the adaptor and the adaptor is in need of replacement (mt-02-219 s18015).This event has ultimately not delayed surgeries, but the surgeon notes it is increasingly difficult to attach the patient to the frame adaptor and has thus requested a new part.
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Event Description
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The company representative reported the need for a new crw frame adaptor.They have to provide extra effort in order to slot the crw frame into the adaptor and the adaptor is in need of replacement (mt-02-219 s18015).This event has ultimately not delayed surgeries, but the surgeon notes it is increasingly difficult to attach the patient to the frame adaptor and has thus requested a new part.
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Manufacturer Narrative
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It was reported that rosas00321 crw frame adaptor, s/n (b)(6), is increasingly difficult to attach to the crw frame.The crw frame adaptor, s/n (b)(6), was not returned for investigation.Therefore, the reported issue can not be confirmed and the root cause can not be determined.Corrected data: b4 date of this report.D9 device availability.G3 date received by manufacturer.H2 if follow-up, what type.H3 device evaluated by manufacturer.H6 adverse event problem.H10 additional narratives/data.
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Search Alerts/Recalls
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