MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2255

Catalog Number 1492255UL01

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 01/23/2023

Event Type  Injury  

Event Description

On 23 january 2023, leica biosystems received a complaint that a user was injured during sectioning on their rm2255 microtome.The injured technician required medical treatment in the form of eight (8) stitches.

• Brand Name: LEICA RM2255
• Type of Device: RM2255
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 16418227
• MDR Text Key: 309979325
• Report Number: 3022446399-2023-00002
• Device Sequence Number: 1
• Product Code: IDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1492255UL01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2023
• Distributor Facility Aware Date: 01/23/2023
• Event Location: Other
• Date Report to Manufacturer: 02/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female