MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2235; MICROTOME

Model Number 1492235EUUL

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 10/12/2015

Event Type  Injury  

Manufacturer Narrative

An investigation of the incident is currently ongoing and a follow up including the outcome of the investigation will be submitted.

Event Description

On (b)(6) 2015, leica biosystems received a complaint that a customer got an injury to his index finger and middle finger during the usage of the microtome.Medical treatment was necessary.

Manufacturer Narrative

The investigation revealed the following: the incident was user related.During the usage of the microtome the user grabbed to a tool which was stored next to the microtome device.Whilst this action the users jacket came to the knife protector of the device and pushed the blade guard downwards.While returning back to the work position the user grasped into the blade of the knifo holder with his left hand, causing lacerations of the index and middle fingers.

• Brand Name: LEICA RM2235
• Type of Device: MICROTOME
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstr. 17-19,; nussloch, 69226 ; GM 69226
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226 ; 6224143
• MDR Report Key: 5212156
• MDR Text Key: 30833431
• Report Number: 8010478-2015-00007
• Device Sequence Number: 1
• Product Code: IDO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 1492235EUUL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other