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

Model Number	HISTOCORE PEGASUS PLUS
Medical Device Problem Codes	Contamination (1120); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024 leica biosystems received a complaint about bad sample quality of tissues processed on a histocore pegasus plus tissue processor.The tissue samples had been processed over night on (b)(6) 2024.
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.
Additional Manufacturer Narrative
According to an investigation report issued on (b)(6) 2024: after evaluation of the information available, it was found that the root cause of the issue was that the overfilled reagent bottles, combined with the design of the air manifold, caused reagent cross-contamination.This cross-contamination in turn negatively impacted the tissue quality.The root cause that has been determined for this incident is identical to the root cause which triggered the ongoing field safety corrective action for the histocore pegasus and histocore pegasus plus.After replacement of the air manifold with a re-designed version of the air manifold and associated manifold tubes, replacement of the condensate bottle and the retort filter, the device was returned to full functionality.On july 30th, 2024, leica biosystems recieved the information that no medical treatment was necessary, and all patient samples were able to be diagnosed.

• Common Device Name: 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: 19123912
• Report Number: 8010478-2024-00010
• Device Sequence Number: 15393544
• Product Code: IEO
• UDI-Device Identifier: 04049188217769
• UDI-Public: (01)04049188217769(11)220808
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: HISTOCORE PEGASUS PLUS
• Device Catalogue Number: 14048858007
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1947-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown