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

Catalog Number 14048858007

Device Problem Insufficient Information (3190)

Patient Problem Tissue Breakdown (2681)

Event Date 03/24/2023

Event Type  Injury  

Manufacturer Narrative

The investigation revealed the following: the instrument logs were analyzed by the lbs senior quality engineer, and no instrument error was detected.Also, leica biosystems field service engineer did not detect any technical anomalies with the instrument during the visit and investigation at customer site.Based on the investigation results, the histocore pegasus plus has been functioned according to the factory specifications.Recommendation from leica application specialist was to check, whether the processing protocol is correctly selected based on the tissue size and type, that the reagent will be changed frequently and the threshold and carryover settings are correctly set as described in the instruction for use.

Event Description

On 05 april 2023 leica biosystems received a complaint that the customer experienced suboptimal tissue processing on their histocore pegasus plus, tissue processor.As a result, 250 cassettes with tissue samples were affected.

• Brand Name: HISTOCORE PEGASUS PLUS
• Type of Device: HISTOCORE PEGASUS PLUS
• 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: 17236342
• MDR Text Key: 318178613
• Report Number: 8010478-2023-00006
• Device Sequence Number: 1
• Product Code: IEO
• UDI-Device Identifier: 04049188217769
• UDI-Public: (01)04049188217769
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/30/2023

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: 14048858007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other