MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH 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  

Event Description

6n 2019, leica biosystems received information that a user of an rm2255 microtome instrument had been injured by the instrument blade.The user sought medical attention and required stitches to their finger.

Event Description

On 29 july 2019, leica biosystems confirmed that the customer was not willing to share any additional information related to this incident.With this updated information, the leica biosystems manufacturer has closed this mdr.

• Brand Name: LEICA RM2255
• Type of Device: LEICA RM2255
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH; heidelberger strasse 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 8696842
• MDR Text Key: 148002813
• Report Number: 1423337-2019-00007
• Device Sequence Number: 1
• Product Code: IDO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/16/2019
• Distributor Facility Aware Date: 05/14/2019
• Event Location: Other
• Date Report to Manufacturer: 08/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other