MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH LEICA CM1950

Model Number 1491950C4US

Device Problem Use of Device Problem (1670)

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

Event Date 03/04/2020

Event Type  Injury  

Event Description

On 09 march 2020, leica biosystems received a complaint that a technician cut her finger during cleaning of the microtome cryostat instrument.No further information or confirmation of medical treatment/intervention was provided by the customer site.Leica biosystems made three (3) attempts to confirm if medical treatment/intervention was required for the injured technician; however, no response has been received.If additional information is received a follow up report will be submitted.

• Brand Name: LEICA CM1950
• Type of Device: LEICA CM1950
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH; heidelberger strasse 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 9860745
• MDR Text Key: 189329544
• Report Number: 1423337-2020-00004
• Device Sequence Number: 1
• Product Code: IDP
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 1491950C4US
• 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: 03/20/2020
• Distributor Facility Aware Date: 03/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other