MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH ASP6025 S

Catalog Number	14049559058
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 18 january 2023 leica biosystems received a complaint that the customer experienced suboptimal tissue processing on their asp6025 s.On (b)(6) 2023 the customer informed leica biosystems, that as a result, 1 tissue samples has not been diagnosed, and the patient has been rebiopsied.The age and gender of the patient is 81, f.
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.
Additional 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.The incident was user related, because the user did proceed big and small tissues together within a 13 hours protocol.Which, is not recommended in the instruction for use (ifu).The recommend protocol for standard biopsy and small specimen is defined in the ifu.Additionally, all alcohols in the processor have been changed.The customer confirmed, that the device has been working correctly, since the change of reagents.Furthermore, the application consultant recommended to the customer, to separate small tissues from the large tissues, during the processing run.
Additional Manufacturer Narrative
Additional information: added unique identifier (udi) # in d4.

• Brand Name: ASP6025 S
• Common Device Name: ASP6025 S
• 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: 16654381
• Report Number: 8010478-2023-00002
• Device Sequence Number: 12416145
• Product Code: IEO
• UDI-Device Identifier: 04049188210777
• UDI-Public: (01)04049188210777
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: 14049559058
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 04/19/2023; 04/19/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 05/04/2023; 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2021
• 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 Age: 81 YR
• Patient Sex: Female