MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1860UV

Catalog Number 1491860UVUS

Device Problem Material Integrity Problem (2978)

Patient Problem Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

No investigation has been conducted to date, because the customer refused to provide additional information.After submitting of a report to the fda regarding this adverse event from the customer, we will obtain a copy of this report, and can submit a follow-up report with more detailed information.

Event Description

On 12 october 2021, leica biosystems received a complaint that a patient tissue was undiagnosed due to sectioning issues with the instrument leica cm1860.The customer declined to provide additional information, and mentioned on 18 october 2021, after recommendation with their risk department, they will submit a report to the fda as well, and leica biosystems can retrieve the requested information through the fda data base.

Manufacturer Narrative

Additional information: added unique identifier (udi) # in d4.

• Brand Name: LEICA CM1860UV
• Type of Device: LEICA CM1860UV
• 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: 12785552
• MDR Text Key: 284381755
• Report Number: 8010478-2021-00013
• Device Sequence Number: 1
• Product Code: IDP
• UDI-Device Identifier: 04049188168481
• UDI-Public: (01)04049188168481
• 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,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 1491860UVUS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 10/12/2021
• Supplement Dates FDA Received: 10/30/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other