MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH ASP6025

Catalog Number 14049543267

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/11/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 leica biosystems received the confirmation, that the customer experienced suboptimal tissue processing on their asp6025, tissue processor.As a result the tissue was undiagnosable, and a rebiopsy for 9 patients was recommended.

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

The investigation revealed the following: the instrument logs were analyzed by the lbs senior quality engineer, and no instrument error was detected during the processing steps that could conceivably be linked to the damaged tissue.The incident was presumably user related due to an application issue (thresholds set up).Test runs have been conducted successfully after the changing all reagents and paraffin.According to the lbs senior quality engineer, the purity of the xylene (s8) and paraffin(i) used may have been insufficient to meet processing requirements, which may have caused the tissues to be under processed.Also, the ethanol concentrations in s1, s2, s3 and s4 significantly exceeded the ifu recommendation.A recommendation was made to the customer to optimize the thresholds for the reagents and the paraffin.

• Brand Name: ASP6025
• Type of Device: ASP6025
• 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: 18289924
• MDR Text Key: 329994687
• Report Number: 8010478-2023-00015
• Device Sequence Number: 1
• Product Code: IEO
• 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: 02/12/2024

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 Catalogue Number: 14049543267
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 01/13/2024
• Supplement Dates FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2018
• 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