MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1950

Model Number 1491950C2EU

Device Problem Human-Device Interface Problem (2949)

Patient Problem Injury (2348)

Event Date 06/17/2016

Event Type  Injury  

Manufacturer Narrative

The investigation revealed this incident was user related.The instrument knife holder was inadequately maintained causing the instrument handwheel to become sluggish.While cleaning the knife holder in the chamber of the cryostat, the internal technician did not properly use the blade guard and thus cut his finger.A customer facing letter will be sent out with recommendation in the future to follow the maintenance and safety instructions provided in the instructions for use.

Event Description

An internal technician of a clinical center cut his finger while cleaning the leica cm1950.Stitches were required to close the cut.

• Brand Name: LEICA CM1950
• Type of Device: CM1950
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; gmbh heidelberger strasse 17-19; nussloch, 69226 ; GM 69226
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226 ; 6224143345
• MDR Report Key: 5808049
• MDR Text Key: 49950481
• Report Number: 8010478-2016-00004
• Device Sequence Number: 1
• Product Code: IDP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Service Personnel
• Device Model Number: 1491950C2EU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR