MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH LEICA CM1950

Model Number 491950C3US

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/14/2018

Event Type  Injury  

Event Description

On (b)(4) 2018, leica biosystems received a complaint that a resident of the lab injured himself/herself's finger on the blade of the leica cryostat instrument.According to the complainant, the resident of the lab received the "standard post-exposure prophylaxis" treatment.No further treatment details were provided.If additional information becomes available a follow up report will be submitted.

Event Description

Following the investigation by the leica biosystems manufacturer, it was determined the incident was user related because the user did not follow the instrument safety instructions.The injury was not a result of an instrument malfunction.

Event Description

Device code 2993 was inadvertently entered.Code 2993 does not apply in this instance and has been removed.This correction has been made on this follow up #02 report.

• 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: 8261204
• MDR Text Key: 133546538
• Report Number: 1423337-2019-00001
• Device Sequence Number: 1
• Product Code: IDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 491950C3US
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2019
• Distributor Facility Aware Date: 12/20/2018
• Event Location: Other
• Date Report to Manufacturer: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other