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

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.

• 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 Key: 5899674
• MDR Text Key: 52847139
• Report Number: 8010478-2016-00005
• Device Sequence Number: 1
• Product Code: IDO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 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 Number: 1492255UL01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/10/2016
• Initial Date FDA Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other