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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1850

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LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1850 Back to Search Results
Catalog Number 14901850001
Device Problem Defective Component (2292)
Patient Problem Tissue Breakdown (2681)
Event Date 04/22/2021
Event Type  Injury  
Manufacturer Narrative
The unit has been evaluated by a leica field service engineer. The investigation revealed the following: the root cause was determined to be worn bearings. The customer reported that a 3rd party service engineer observed worn ball bearings in the pressure plate, which has likely caused sectioning issues. The customer declined a leica service visit, and is awaiting a new cryostat currently on backorder.
 
Event Description
On (b)(6) 2021, leica biosystems received a complaint that a tissue sample was lost during the cutting with the instrument leica cm1850. As a result for one patient a rebiopsy has been recommended. We attempted to obtain patient identifier information but the customer has not responded to our inquiries.
 
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Brand NameLEICA CM1850
Type of DeviceLEICA CM1850
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 Key11854256
MDR Text Key251689645
Report Number8010478-2021-00006
Device Sequence Number1
Product Code IDP
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
Type of Report Initial
Report Date 05/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number14901850001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2021
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
Type of Device Usage

Patient Treatment Data
Date Received: 05/20/2021 Patient Sequence Number: 1
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