Model Number BB511 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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It was reported that there was an issue with bb511-carbon steel scalpel blades #11.According to the complaint description, the scalpel blade no.11 bbraun (lot: k9356329), presents loss of the wire in advance, requiring extra consumption.There was no described patient harm.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under (b)(4).
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Manufacturer Narrative
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Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the lack of onformation it is not possible to checked the device history records.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.
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Search Alerts/Recalls
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