MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH; PROCESSOR, TISSUE, AUTOMATED

Model Number HISTOCORE PEGASUS PLUS

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

On 11 march 2024 leica biosystems received a complaint about a densitometer error of the histocore pegasus plus, tissue processor.On 25 march 2024 further information was received that samples that had been processed on the tissue processor on (b)(6) 2024, (b)(6) 2024 and (b)(6) 2024 were negatively impacted and had a burnt appearance under the microscope.

Manufacturer Narrative

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

• Type of Device: PROCESSOR, TISSUE, AUTOMATED
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; nussloch 69226 ; GM 69226
• Manufacturer (Section G): LEICA MICROSYSTEMS LTD. SHANGHAI; building 1, 258 jinzang road; shanghai,pudong 20120 6; CH 201206
• Manufacturer Contact: robert gropp ; heidelbergerstrasse 17-19; nussloch 69226 ; GM 69226 ; 6224143345
• MDR Report Key: 19069646
• MDR Text Key: 339677782
• Report Number: 8010478-2024-00009
• Device Sequence Number: 1
• Product Code: IEO
• UDI-Device Identifier: 04049188217769
• UDI-Public: (01)04049188217769(11)221212
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HISTOCORE PEGASUS PLUS
• Device Catalogue Number: 14048858007
• Distributor Facility Aware Date: 03/11/2024
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1