MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1950

Model Number 1491950C5EU

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 05/29/2017

Event Type  Injury  

Manufacturer Narrative

An investigation of the incident is currently underway and a follow up will be submitted, if additional information become available following the investigation.

Event Description

On (b)(6) 2017, the customer reported a damaged tissue after cutting on their leica cm1950.As a result, the tissue could not be diagnosed and one patient is confirmed to require rebiopsy.

Manufacturer Narrative

The investigation revealed the following: the logs of the affected instrument were analyzed and no technical issues were detected with the microtome component of the (b)(4) instrument.The issue could not be replicated.A preventive maintenance was performed.Additionally cutting tests were performed with the user to verify the operation without further issues.The cutting tests passed.The conclusion is that this was a single case event and the affected customer site is fully functional following a preventive maintenance.No further actions are required.

• Brand Name: LEICA CM1950
• Type of Device: CM1950
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelberger strasse 17-19; nussloch, 69226 ; GM 69226
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226 ; 6224143345
• MDR Report Key: 6669318
• MDR Text Key: 78460037
• Report Number: 8010478-2017-00005
• Device Sequence Number: 1
• Product Code: IDP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1491950C5EU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2008
• 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: 62 YR