MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2255; MICROTOME

Model Number 1492255UL01

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 10/20/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, leica biosystems was notified that a lab tech injured (cut) his finger during usage of the microtome instrument.Medical treatment was necessary.According to the customer, the incident occurred on (b)(6) 2017.As per the manufacturer investigation, the user disregarded the instrument safety instructions resulting in the injury.Safety training was performed with the user following this incident.

• Brand Name: LEICA RM2255
• Type of Device: MICROTOME
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 7100546
• MDR Text Key: 94270573
• Report Number: 1423337-2017-00020
• Device Sequence Number: 1
• Product Code: IDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/08/2017,11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 1492255UL01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2017
• Distributor Facility Aware Date: 11/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other