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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2255; MICROTOM, PRODUCT CODE: IDO

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LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2255; MICROTOM, PRODUCT CODE: IDO Back to Search Results
Model Number 1492255UL01
Device Problem Human Factors Issue (2948)
Patient Problem Injury (2348)
Event Date 08/10/2016
Event Type  Injury  
Manufacturer Narrative
This incident was user related.While installing the object holder on new microtome rm2255 the leica biosystems employee didn't realize the customer had placed a blade in the blade holder.The blade holder moved and he cut his finger.He required stitches.The instructions for use includes the following safety instructions: "when working with microtomes, personal safety precautions must always be taken.It is mandatory to wear work safety shoes, safety gloves, a mask and safety goggles.Take care when handling microtome knives and disposable blades.The cutting edge is extremely sharp and can cause serious injuries!".
 
Event Description
A leica biosystems employee was installing a new microtome rm2255 on customer site and caused a cutting damage on his finger.Medical treatment was necessary.
 
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Brand Name
LEICA RM2255
Type of Device
MICROTOM, PRODUCT CODE: IDO
Manufacturer (Section D)
LEICA BIOSYSTEMS NUSSLOCH GMBH
heidelbergerstr. 17
nussloch, 69226
GM  69226
Manufacturer Contact
robert gropp
heidelbergerstr. 17-19
nussloch, 69226
GM   69226
9622414334
MDR Report Key5899674
MDR Text Key52847139
Report Number8010478-2016-00005
Device Sequence Number1
Product Code IDO
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
Report Date 08/10/2016
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 Operator No Information
Device Model Number1492255UL01
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/10/2016
Initial Date FDA Received08/24/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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