BLUE BELT TECHNOLOGIES HANDPIECE, EMAX 2 PLUS (ANSPACH DRILL), ROHS COMPLIANT; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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Catalog Number PFSR101209 |
Device Problem
Defective Component (2292)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/03/2019 |
Event Type
malfunction
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Event Description
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It was reported that during a demo case, e8 error on drill during drill test, then tried on different machine and e8 error again.Investigation results determined an internal wiring damage, which makes it a reportable event.
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Manufacturer Narrative
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H10 h3, h6: the device was intended to use in treatment and it was reported that the drill displayed e8 error during drill test.The drill was returned for investigation.Dhr review found that no conditions which could contribute to the reported event were identified.This information is reasonably suggesting that the device met the specifications at the date when it was released to the distribution.A complaint history found similar reports.We could confirm there was a relationship established between the reported event and the device.The device was returned for investigation.A drill test was performed and the drill showed to be spinning at 2000 rpm and there was an abnormal noise.Then, there was an e2 error on the console.The drill was unplugged and plugged back in.The console showed an e8 error and the drill would no spin.Then the drill was unplugged and plugged back in, and the lights on the console did not light up to indicate that a drill was plugged in.The drill was returned to the oem for service.The root cause after investigation was established to be supplier / raw material fault.
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