Catalog Number C2602 |
Device Problem
Output Problem (3005)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
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Event Description
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A distributor reported that the c2602 excel 36khz straight handpiece was rejected during their incoming inspection of goods because when using the handpiece with the c4614s tip, a vibration alarm occurred with the test mode on (b)(6) 2019.Additional information has been received on 08aug2019 that there was no required revision or medical intervention.
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Event Description
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N/a.
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Manufacturer Narrative
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Udi - (b)(4).The device was returned for evaluation.The technician found that the handpiece had delamination of the stack.The dhr documentation was reviewed and no anomalies that could be associated with the complaint incident was observed.The complaint was verified as valid.The root cause was found to be a faulty transducer - delamination.
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Search Alerts/Recalls
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