MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2235; NONE

Model Number 1492235EUUL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 01/19/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, leica biosystems received a complaint that a customer got an injury to her left thumb during the usage of the microtome.Med treatment was necessary.

Manufacturer Narrative

The investigation revealed the following: this incident is presumably user related because the user did not lock the handwheel, per the user manual revision.The locking mechanism has been checked by a leica service engineer.The instrument is operating within spec.A customer facing letter will be send to the customer with recommendation in future to follow the description provided in the instruction for use.

• Brand Name: LEICA RM2235
• Type of Device: NONE
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelberger str. 17-19; nussloch 6922 6
• Manufacturer Contact: robert gropp ; heidelberger str. 17-19; nussloch 69226 ; GM 69226 ; 224143345
• MDR Report Key: 4567331
• MDR Text Key: 18086727
• Report Number: 8010478-2015-00001
• Device Sequence Number: 1
• Product Code: IDO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1492235EUUL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other