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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2255; ROTARY MICROTOME,

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LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2255; ROTARY MICROTOME, Back to Search Results
Model Number 1492255UL01
Device Problems Use of Device Problem (1670); Human Factors Issue (2948); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Laceration(s) (1946); Injury (2348)
Event Date 07/07/2015
Event Type  Injury  
Event Description
On (b)(6) 2015 while on-site servicing another instrument, a leica biosystems field service engineer (fse) was notified by a user that earlier in the summer, she cut the end of her finger off while using the leica rm2255.Per the user, the injury occurred on (b)(6) 2015.The user was treated for her injury at (b)(6) and they were able to reattach the end of her finger.This incident was not initially reported to leica biosystems but was reported to the hospital, (b)(6).
 
Event Description
The leica manufacturer completed their investigation and found that this incident was presumably user related.While the users fingertip was in the cutting area, she activated the cutting process via the foot pedal.Safety gloves were not worn, as described in the instruction for use: "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." a customer facing letter will be sent out with recommendation in future to follow the description provided in the instruction for use.
 
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Brand Name
LEICA RM2255
Type of Device
ROTARY MICROTOME,
Manufacturer (Section D)
LEICA BIOSYSTEMS NUSSLOCH GMBH
17-19 heidelbergerstr.
nussloch, 69226
GM  69226
MDR Report Key5099168
MDR Text Key26589941
Report Number1423337-2015-00018
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
Type of Report Followup
Report Date 01/29/2016,08/24/2015
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 Health Professional
Device Model Number1492255UL01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/29/2016
Distributor Facility Aware Date08/24/2015
Event Location Hospital
Date Report to Manufacturer01/29/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/23/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/30/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age36 YR
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