MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2235

Catalog Number 1492235EUUL

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

Patient Problem Laceration(s) (1946)

Event Date 08/10/2021

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 (b)(6) 2021, leica biosystems received a complaint that a user was injured during sectioning on their microtome, rm2235.The injured user required medical assistance in the form of stitches.

Manufacturer Narrative

The investigation revealed that the incident was user related.Before starting to cut on the microtome, the user placed the pencil for labelling the slides on the wrong (left) side of the microtome.After the first cut, the user needed the pencil, which resulted in reaching with the right hand over the free-standing blade to pick up the pencil from the left side of the microtome.Because she was not wearing safety gloves and had not covered up the blade with the safety guard, she suffered a cutting injury to her finger on the right hand.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: 12490722
• MDR Text Key: 272126290
• Report Number: 8010478-2021-00011
• Device Sequence Number: 1
• Product Code: IDO
• UDI-Device Identifier: 04049188002242
• UDI-Public: (01)04049188002242
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1492235EUUL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• 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