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

Model Number HISTOCORE PEGASUS

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024 leica biosystems received a complaint that the customer experienced suboptimal tissue processing on their histocore pegasus.As a result, 3 tissue samples need to be recollected (2 gastric biopsy samples and 1 esophageal sample).

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.

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 crosscontamination.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
• 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; 20120 6; CH 201206
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch 69226 ; GM 69226 ; 6224143345
• MDR Report Key: 18814625
• MDR Text Key: 336615263
• Report Number: 8010478-2024-00003
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 05/29/2024

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
• Device Operator: Health Professional
• Device Model Number: HISTOCORE PEGASUS
• Device Catalogue Number: 14048858005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/02/2024
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• 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
• Patient Outcome(s): Other