MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2235

Catalog Number 1492235USUH

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation.

Event Description

On 31 august 2021, leica biosystems received a complaint that a user was injured during sectioning on their microtome, rm2235.The injured user required medical assistance.

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 and preparing of slides, the technician sliced her finger over the free-standing blade.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.The injury was not a result of an instrument malfunction.

Manufacturer Narrative

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

• Brand Name: LEICA RM2235
• Type of Device: RM2235
• 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: 12536718
• MDR Text Key: 273536997
• Report Number: 8010478-2021-00012
• Device Sequence Number: 1
• Product Code: IDO
• UDI-Device Identifier: 04049188002228
• UDI-Public: (01)04049188002228
• 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,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1492235USUH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2008
• 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