MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2255

Model Number 1492255UL01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/29/2019

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 an employee of the customer injured himself on a leica rm2255 microtome blade.Employee needed medical attention that resulted in stitches to their finger.

Event Description

On 14 may 2019, leica biosystems received a complaint that an employee of the customer was injured on a leica rm2255 microtome blade.Employee needed medical attention that resulted in stiches to their finger.

Manufacturer Narrative

Event: removed "himself", because the gender of the employee was not exactly provided.Due to the fact that the customer was not willing to share any additional information related to this incident, we have closed this mdr.

• Brand Name: LEICA RM2255
• Type of Device: LEICA RM2255
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 8695202
• MDR Text Key: 147859548
• Report Number: 8010478-2019-00005
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1492255UL01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other