Model Number PELORIS II |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Tissue Damage (2104); Injury (2348)
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Event Date 09/21/2016 |
Event Type
Injury
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Event Description
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Leica biosystems received a complaint that processed tissue cassettes showed poor morphology.On 21 september 2016, leica biosystems received confirmation that seven (7) cases from that processing run had to be rebiopsied.Patient identifier information was provided for all cases and separate reports have also been submitted for all cases.Report numbers for all cases are as follows: 1423337-2016-00010, 1423337-2016-00011, 1423337-2016-00012, 1423337-2016-00013, 1423337-2016-00014, 1423337-2016-00015 and 1423337-2016-00016.Please refer to these reports for specific details of the other patients involved.
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Event Description
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Following the investigation by the leica manufacturer, the root cause of the sub-optimal tissue processing could not be determined from the information available.No use error(s) was identified in the instrument logs and no instrument failure was detected; the device operated within specification.See manufacturer report 8020030-2016-00068, 8020030-2016-00069, 8020030-2016-00070, 8020030-2016-00071, 8020030-2016-00072, 8020030-2016-00073 or 8020030-2016-00074 for more information.
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Search Alerts/Recalls
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