Catalog Number 14048858007 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Tissue Breakdown (2681)
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Event Date 07/29/2023 |
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 07 august 2023 leica biosystems received a complaint that the customer experienced suboptimal tissue processing on their histocore pegasus plus.As a result, 22 samples needed to be recollected.
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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 incident was presumable user related and caused by the usage of the incorrect processing protocol.The customer processed tissues and biopsy tissue together with the "biopsy protocol" processing protocol.It will be difficult to obtain this confirmation from the customer, since he is not willing to coorperate and to provide more information.
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Search Alerts/Recalls
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