MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE PEGASUS; HISTOCORE PEGASUS PLUS

Catalog Number	14048858005
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The complainant contacted leica biosystems (lbs) to report a histocore pegasus tissue processing protocol failure, which impacted the tissue.On (b)(6) 2023, the complainant initially reported to lbs that all tissue was diagnosable.However, on (b)(6) 2023, the complainant informed lbs that ihc (immunohistochemistry) was unable to be properly performed and further recommended re-biopsy.One (1) breast specimen was not entirely diagnosable due to inability to run testing marker.When asked if the state of health of the patient had been adversely affected by a medical decision or action either taken or not taken due to this event, the complainant replied, "n/a although delays in care, full diagnosis and having to undergo another biopsy have all occurred.".
Event or Problem Description
The leica biosystems (lbs) manufacturer conducted an investigation of this event and determined the incident was user related and was most likely caused by an air tube blockage, which in turn caused the instrument to report an error.This led to the affected tissue sitting idle for 2 hours in xylene in retort a and caused the observed tissue damage to occur.Based on the investigation results and the actions conducted with the instrument at the customer site, the manufacturer confirms the instrument, at this time, is working according to factory specifications.To avoid a recurrence of the same issue in the future, a customer facing letter was sent out to the customer with recommendations to consider the countermeasures defined in the instrument instruction for use (ifu) regarding the air tube blockage.The lbs manufacturer's report, 8010478-2023-00011, contains additional information regarding the investigation and root cause.

• Brand Name: HISTOCORE PEGASUS
• Common Device Name: HISTOCORE PEGASUS PLUS
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 17886741
• Report Number: 3022446399-2023-00006
• Device Sequence Number: 7551522
• Product Code: IEO
• UDI-Device Identifier: 04049188216397
• UDI-Public: 04049188216397
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023
• Report Date (Section F): 11/28/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 14048858005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/28/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female
• Date Report Sent to FDA: 11/28/2023