Catalog Number 14048858005 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/15/2023 |
Event Type
Injury
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Manufacturer Narrative
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An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation.
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Event Description
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On (b)(6) 2023 leica biosystems received a complaint that the customer experienced suboptimal tissue processing on their asp6025, tissue processor.The customer informed leica biosystems, that as a result, 20 tissue samples have not been diagnosed.
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Manufacturer Narrative
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The investigation revealed the following: the instrument logs were analyzed by the lbs senior quality engineer, and no instrument error was detected during the processing steps related to the damaged tissue.The instrument is working according to factory specifications.The incident was user related and caused by the fixation and usage of the incorrect assignment of the carryover value setting for created or edited protocols.If the setup of carryover is lower than the actual carryover, it may potentially cause tissue damage (mainly under-processed tissue).A customer facing letter was sent out to the customer with recommendation, to consider the carryover setting and to use the recommended accordingly the protocol for standard biopsy and small specimen as defined in the instruction for use (ifu).
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Search Alerts/Recalls
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