MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE PEARL

Catalog Number 14049350667

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/19/2023

Event Type  Injury  

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.

Event Description

On (b)(6) 2023, a customer reported to leica biosystems that on (b)(6) 2023 they experienced suboptimal tissue processing on their histocore pearl.As a result one (1) breast resection tissue sample was lost, and it is not possible to collect tissue from the patient again.

Manufacturer Narrative

The investigation revealed the following: the instrument logs were analyzed by the lbs senior quality engineer.The broken sd (secure digital memory card) data from the defect electronic box has been recovered, and according to the log files, the leica quality engineer found the last log of the instrument was around at 20:35:46 pm on (b)(6) 2023.After that, all sensor and log data were gone.From the log on (b)(6) , the instrument was in normal working condition before the shutdown, without any errors or error codes.The leica quality engineer tried a variety of ways to recover the lost data, but this was not possible.Therefore, no root cause could be defined.

• Brand Name: HISTOCORE PEARL
• Type of Device: HISTOCORE PEARL
• 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: 18159250
• MDR Text Key: 328394493
• Report Number: 8010478-2023-00014
• Device Sequence Number: 1
• Product Code: IEO
• UDI-Device Identifier: 04049188198907
• UDI-Public: (01)04049188198907
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 04/05/2024

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: 14049350667
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2018
• 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