MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE PEGASUS

Catalog Number	4048858005
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/27/2023
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
On 09 january 2024 leica biosystems received a complaint that the customer experienced suboptimal tissue processing on their histocore pegasus.As a result, 2 tissue samples need to be recollected.
Additional Manufacturer Narrative
As part of our post market surveillance, we have identified an issue related to poorly processed or damaged biopsy tissue specimens on the histocore pegasus and histocore pegasus plus systems.The problem is associated with reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks.The overfilling of reagents by users, excess reagent carried from the basket during initial loading, or excessive reagent in the biopsy pads/wraps can lead to reagent levels surpassing the maximum fill level mark.As a result, excess reagent may flow into other bottles through the air manifold during a processing protocol, causing cross-contamination.Due to the fact, that we have received one (1) more mdr regarding the safety issue described, it has been decided to initiate a field action.A capa has been started to identify detailed countermeasures.The first step to address this issue will be to send a fa-notice to the customer to provide information about the possibly hazardous situations regarding reagent overfilling.In addition, the fa-notice will contain information that leica biosystems service will contact the customer to perform an upgrade of the instrument.The second step will be that leica biosystems service will contact the customer to schedule the upgrade of the instrument with the new manifold.Three (3) attempts will be made to contact each customer.The general strategy is to use at least 2 different channels like email and phone contact.There may be some country specific exemptions.Effectiveness check/target response rate: for the countries where this fa is reportable, we aim for a 100 % response rate.For countries where the fa is not reportable, we aim for a 75% response rate.

• Brand Name: HISTOCORE PEGASUS
• Common Device Name: HISTOCORE PEGASUS
• 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 ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 18665108
• Report Number: 8010478-2024-00002
• Device Sequence Number: 12580571
• Product Code: IEO
• UDI-Device Identifier: 04049188216397
• UDI-Public: (01)04049188216397
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 4048858005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown