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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH; PROCESSOR, TISSUE, AUTOMATED
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LEICA BIOSYSTEMS NUSSLOCH GMBH; PROCESSOR, TISSUE, AUTOMATED Back to Search Results
Model Number HISTOCORE PEGASUS PLUS
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 03/15/2024
Event Type  malfunction  
Event Description
On (b)(6) 2024 leica biosystems received a complaint about bad sample quality of tissues processed on a histocore pegasus plus tissue processor.The tissue samples had been processed over night on (b)(6) 2024.
 
Manufacturer Narrative
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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Type of Device
PROCESSOR, TISSUE, AUTOMATED
Manufacturer (Section D)
LEICA BIOSYSTEMS NUSSLOCH GMBH
heidelbergerstrasse 17-19
nussloch 69226
GM  69226
Manufacturer (Section G)
LEICA MICROSYSTEMS LTD. SHANGHAI
building 1, 258 jinzang road
shanghai,pudong 20120 6
CH   201206
Manufacturer Contact
robert gropp
heidelbergerstrasse 17-19
nussloch 69226
GM   69226
6224143345
MDR Report Key19123912
MDR Text Key340351695
Report Number8010478-2024-00010
Device Sequence Number1
Product Code IEO
UDI-Device Identifier04049188217769
UDI-Public(01)04049188217769(11)220808
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 04/17/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHISTOCORE PEGASUS PLUS
Device Catalogue Number14048858007
Distributor Facility Aware Date03/18/2024
Date Manufacturer Received03/18/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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