MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM3030S; CM3050S

Catalog Number 14903050S01

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 12/18/2023

Event Type  Injury  

Event Description

On 18 december 2023, leica biosystems was informed that a user cut their finger on the cryostat instrument blade.According to the complainant, "they were slicing a tissue sample with a razor blade to prepare it for dissection and cut themselves on the blade of the machine." on (b)(6) 2023, leica biosystems obtained additional information that the injured user sought medical treatment at a local urgent care facility.On (b)(6) 2024, the complainant provided an update on the request for information regarding the medical treatment received by the injured user.The complainant confirmed that the injured user received wound care with steri-strips to the injured finger and was also provided an antibiotic.

• Brand Name: LEICA CM3030S
• Type of Device: CM3050S
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 18531716
• MDR Text Key: 333088066
• Report Number: 3022446399-2024-00001
• Device Sequence Number: 1
• Product Code: IDP
• UDI-Device Identifier: 04049188003270
• UDI-Public: (01)04049188003270
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 14903050S01
• 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: 01/17/2024
• Distributor Facility Aware Date: 12/18/2023
• Event Location: Other
• Date Report to Manufacturer: 01/17/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other