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

Catalog Number 14048858005

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/08/2023

Event Type  Injury  

Event 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 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
• Type of Device: HISTOCORE PEGASUS PLUS
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 17886741
• MDR Text Key: 325116269
• Report Number: 3022446399-2023-00006
• Device Sequence Number: 1
• Product Code: IEO
• UDI-Device Identifier: 04049188216397
• UDI-Public: 04049188216397
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 11/28/2023
• Distributor Facility Aware Date: 09/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female