Model Number 14047643514 |
Device Problems
Human-Device Interface Problem (2949); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problems
Tissue Damage (2104); Injury (2348)
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Event Date 08/12/2015 |
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 info become available following the investigation.
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Event Description
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On (b)(6) 2015, the customer reported suboptimal tissue after processing on their leica asp300.As a result, some specimens could not be diagnosed and one pt is confirmed to require rebiopsy.
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Manufacturer Narrative
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The unit has been evaluated by a leica application specialist.The investigation revealed the following: the root cause is determined to be the usage of a basket without the anti-reflection clip and a dirty level sensor.After the event the level sensors were cleaned and the anti-reflection clip installed, the customer conducted a new processing run which confirmed the proper functioning of the unit.A customer facing letter will be sent to the customer with the reference in future to follow the recommendation in the customer letter regarding the usage of the anti-reflection clip and the periodic cleaning of the level sensors.This final report is in reference to the initial report 8010478-2015-0004.
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Search Alerts/Recalls
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