Model Number 7209807- |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/08/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter: occurred after the procedure.The prong came off.There was no patient involvement, no patient injury, and no medical intervention required.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Complaint of broken spigot was confirmed.There is rust visible around where tube has broken off.Spigot has never been replaced and is 2 and a half years old.Other than the damage to spigot the mdu passes functional testing including high speed testing (100-2500 rpms) with blade installed.Unit passed functional tests on a known good control unit with footswitch.The complaint investigation has concluded that this unit has succumbed to normal wear and tear.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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