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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE AUTOCUT
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LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE AUTOCUT Back to Search Results
Catalog Number 149AUTO00C1
Device Problem Use of Device Problem (1670)
Patient Problem Laceration(s) (1946)
Event Date 06/17/2021
Event Type  Injury  
Event Description
On (b)(6) 2021, leica biosystems received a complaint that a user (lab technician) was injured during sectioning on their microtome, histocore autocut.The lab technician cut a piece of her finger and chipped the bone and had to be taken to the emergency room, consult with a plastic surgeon and is on medical leave.The injury occurred when she went to remove the tissue block she was roughing.The technician had not used automated microtomes prior to use of the histocore autocut microtome and was not experienced with the advancing feature of the microtome.Customer training was provided at the time of purchase/installation and another customer training session was scheduled for (b)(6) 2021.The tissue in the block that was in the microtome at the time of the incident was not adversely affected.
 
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Brand Name
HISTOCORE AUTOCUT
Type of Device
HISTOCORE AUTOCUT
Manufacturer (Section D)
LEICA BIOSYSTEMS NUSSLOCH GMBH
heidelbergerstrasse 17-19
nussloch, 69226
GM  69226
MDR Report Key12185462
MDR Text Key263474007
Report Number1423337-2021-00007
Device Sequence Number1
Product Code IDO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number149AUTO00C1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/16/2021
Distributor Facility Aware Date06/17/2021
Event Location Hospital
Date Report to Manufacturer07/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age33 YR
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