MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2235

Model Number 1492235EUUL

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 08/23/2019

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) 2019, leica biosystems received a complaint that a user was injured during routine sectioning on their microtome, rm2235.The injured user required medical assistance in the form of bandaging; no stitches were required.To ensure the wound is healing, a doctor and physical therapist are following up with the user.This is the extent of the incident and injury detail provided by the lab supervisor.

Manufacturer Narrative

The investigation revealed that this incident was user related.The user did not utilize the knife guard while sectioning with the microtome instrument.The injury was not a result of an instrument malfunction.A customer facing letter will be sent out with recommendation in the future to follow the maintenance and safety instructions provided in the instructions for use and how to properly use the knife guard while sectioning.

• Brand Name: LEICA RM2235
• Type of Device: LEICA RM2235
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 9217269
• MDR Text Key: 163177753
• Report Number: 8010478-2019-00007
• Device Sequence Number: 1
• Product Code: IDO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1492235EUUL
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other