MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE PEARL

Catalog Number	14049350667
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	03/26/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
On (b)(6) 2022, a customer reported to leica biosystems that on (b)(6) 2022 they experienced suboptimal tissue processing on their histocore pearl.As a result the tissue was undiagnosable, and a rebiopsy for 2 patients was recommended.
Additional Manufacturer Narrative
The incident was instrument related about a level sensor heating problem.Due to this issue, the specimens were not covered by 70% alcohol reagent of station s3 for about 18 minutes.The retort temperature was also around 40 degrees celsius during this period, which is too low for the tissue processing.The temperature of the tissue processing protocol used by the customer and recommended by leica biosystems nussloch should be 45 degrees celsius.The leica biosystems service customer and service engineering manager recommended to replace the level sensor.Further recommendation from the leica biosystems field applications specialist was to maintain and replace the cleaning reagent on a regular basis, and to clean the level sensor as described in the instruction for use.

• Brand Name: HISTOCORE PEARL
• Common Device Name: 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: 14216699
• Report Number: 8010478-2022-00003
• Device Sequence Number: 17512857
• Product Code: IEO
• UDI-Device Identifier: 04049188198907
• UDI-Public: (01)04049188198907
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 14049350667
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 05/31/2022; 05/31/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 06/08/2022; 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Unknown