Catalog Number 4100125000 |
Device Problems
Disassembly (1168); Metal Shedding Debris (1804)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/25/2015 |
Event Type
malfunction
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Event Description
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It was reported that during testing during a procedure at the user facility the device was producing metal particles.The procedure was completed without a clinically significant delay; no medical intervention or adverse consequences were reported.
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Event Description
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It was reported that during testing during a procedure at the user facility the device was producing metal particles.The procedure was completed without a clinically significant delay; no medical intervention or adverse consequences were reported.It was also reported that during testing conducted at the manufacturer facility the device was missing the bearings.No patient involvement, no delay, no medical intervention, and no adverse consequences were reported with this event.
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Manufacturer Narrative
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Excessive stress, as well as the age and use of the device, is known to cause or contribute to the reported event.
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Event Description
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It was reported that during testing during a procedure at the user facility, the device was producing metal particles.The procedure was completed without a clinically significant delay; no medical intervention or adverse consequences were reported.It was also reported that during testing conducted at the manufacturer facility, the device was missing the bearings.No patient involvement, no delay, no medical intervention, and no adverse consequences were reported with this event.
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Search Alerts/Recalls
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