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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1860UV

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LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1860UV Back to Search Results
Catalog Number 1491860UVUS
Device Problem Material Integrity Problem (2978)
Patient Problem Tissue Breakdown (2681)
Event Type  Injury  
Manufacturer Narrative
No investigation has been conducted to date, because the customer refused to provide additional information.After submitting of a report to the fda regarding this adverse event from the customer, we will obtain a copy of this report, and can submit a follow-up report with more detailed information.
 
Event Description
On 12 october 2021, leica biosystems received a complaint that a patient tissue was undiagnosed due to sectioning issues with the instrument leica cm1860.The customer declined to provide additional information, and mentioned on 18 october 2021, after recommendation with their risk department, they will submit a report to the fda as well, and leica biosystems can retrieve the requested information through the fda data base.
 
Manufacturer Narrative
Additional information: added unique identifier (udi) # in d4.
 
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Brand Name
LEICA CM1860UV
Type of Device
LEICA CM1860UV
Manufacturer (Section D)
LEICA BIOSYSTEMS NUSSLOCH GMBH
heidelberger strasse 17-19
nussloch, 69226
GM  69226
Manufacturer Contact
robert gropp
heidelbergerstr. 17-19
nussloch, 69226
GM   69226
MDR Report Key12785552
MDR Text Key284381755
Report Number8010478-2021-00013
Device Sequence Number1
Product Code IDP
UDI-Device Identifier04049188168481
UDI-Public(01)04049188168481
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Catalogue Number1491860UVUS
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/12/2021
Initial Date FDA Received11/10/2021
Supplement Dates Manufacturer Received10/12/2021
Supplement Dates FDA Received10/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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