MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1850

Catalog Number 14901850001

Device Problem Defective Component (2292)

Patient Problem Tissue Breakdown (2681)

Event Date 04/22/2021

Event Type  Injury  

Manufacturer Narrative

The unit has been evaluated by a leica field service engineer.The investigation revealed the following: the root cause was determined to be worn bearings.The customer reported that a 3rd party service engineer observed worn ball bearings in the pressure plate, which has likely caused sectioning issues.The customer declined a leica service visit, and is awaiting a new cryostat currently on backorder.

Event Description

On (b)(6) 2021, leica biosystems received a complaint that a tissue sample was lost during the cutting with the instrument leica cm1850.As a result for one patient a rebiopsy has been recommended.We attempted to obtain patient identifier information but the customer has not responded to our inquiries.

• Brand Name: LEICA CM1850
• Type of Device: LEICA CM1850
• 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
• MDR Report Key: 11854256
• MDR Text Key: 251689645
• Report Number: 8010478-2021-00006
• Device Sequence Number: 1
• Product Code: IDP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 14901850001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2003
• 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