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Lot Number RP001580 |
Device Problem
Unstable (1667)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2022 |
Event Type
malfunction
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Event Description
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It was reported that the speed was unstable.A rotapro console was selected for use.During the procedure, the dynaglide rpm was at about 120,000 rpm and the normal rpm was unstable.Even after replacing the burr, the situation did not change and then the device was replaced with another of the same console.No patient complications reported.
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Event Description
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It was reported that the speed was unstable.A rotapro console was selected for use.During the procedure, the dynaglide rpm was at about 120,000 rpm and the normal rpm was unstable.Even after replacing the burr, the situation did not change and then the device was replaced with another of the same console.No patient complications reported.
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Manufacturer Narrative
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Device evaluated by mfr: the complaint device was received for product analysis.Rotapro rp001580 failed final functional test step 5 offset normal mode minimum flow rate and it was at 111.933 schf.That failure impacted dynaglide which caused high rpm.The reported complaint was confirmed.Tested with the gold pneumatic kit in it and the console passed final functional test, replace pneumatic kit.Console failed visual inspection due to a misalignment/gap from the front panel.No other issues were identified during the product analysis.
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Search Alerts/Recalls
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