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 microtome, rm2255.The injured user required medical assistance in form of stitches.

Manufacturer Narrative

The investigation revealed the following: the incident was user related because the user disregarded the safety instructions.During the cutting of tissue blocks, the new technician sliced her finger on the microtome.Because the customer was not wearing safety gloves and had not covered up the blade with the safety guard, she suffered a cutting injury to her finger.A retraining for the new technician has been performed by the customer supervisor.

Manufacturer Narrative

Additional information: added unique identifier (udi) # in d4.

• Brand Name: LEICA RM2255
• Type of Device: RM2255
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; nussloch, 69226 ; GM 69226
• Manufacturer (Section G): LEICA MICROSYSTEMS LTD. SHANGHAI; building 1, 258 jinzang road; shanghai,pudong, 20120 6; CH 201206
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 16408608
• MDR Text Key: 309871639
• Report Number: 8010478-2023-00001
• Device Sequence Number: 1
• Product Code: IDO
• UDI-Device Identifier: 04049188002105
• UDI-Public: (01)04049188002105
• 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,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• 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?: No
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female