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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2235
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LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2235 Back to Search Results
Model Number 14D22350001
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Laceration(s) (1946); Injury (2348)
Event Date 09/23/2019
Event Type  Injury  
Manufacturer Narrative
An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation.
 
Event Description
On (b)(6) 2019, leica biosystems received a complaint that a user was injured during routine sectioning on their microtome, rm2235.Medical treatment was necessary.
 
Manufacturer Narrative
The investigation revealed the following: the incident was user related because the user disregarded the safety instructions.The injury was not a result of an instrument malfunction.A customer facing letter will be sent out with recommendation, in the future to follow the maintenance and safety instructions provided in the instructions for use.
 
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Brand Name
LEICA RM2235
Type of Device
LEICA RM2235
Manufacturer (Section D)
LEICA BIOSYSTEMS NUSSLOCH GMBH
heidelbergerstr. 17-19
nussloch, 69226
GM  69226
MDR Report Key9217245
MDR Text Key163177564
Report Number8010478-2019-00008
Device Sequence Number1
Product Code IDO
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number14D22350001
Was Device Available for Evaluation? Yes
Date Manufacturer Received09/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age26 YR
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