MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1950

Model Number 1491950C4US

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

The field service specialist tried three times to contact the customer with no response.No further information or confirmation of medical treatment was provided by the customer.

Event Description

On (b)(6) 2020, leica biosystems received a complaint that the customer cut her finger during the cleaning of the microtome cryostat.No further information or confirmation of medical treatment was provided by the customer.

Manufacturer Narrative

Follow up #01: additional device code 1670 added.

• Brand Name: LEICA CM1950
• Type of Device: LEICA CM1950
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelberger strasse 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 9853305
• MDR Text Key: 184321475
• Report Number: 8010478-2020-00005
• Device Sequence Number: 1
• Product Code: IDP
• 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: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1491950C4US
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other