MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH; PROCESSOR, TISSUE, AUTOMATED

Model Number	HISTOCORE PEGASUS PLUS
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
On 11 march 2024 leica biosystems received a complaint about a densitometer error of the histocore pegasus plus, tissue processor.On 25 march 2024 further information was received that samples that had been processed on the tissue processor on (b)(6) 2024, (b)(6) 2024 and (b)(6) 2024 were negatively impacted and had a burnt appearance under the microscope.
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
On 23 july 2024: the leica biosystems customer support department confirmed that, as per feedback from the customer: not all samples were diagnosable, but that since there were multiple samples per patient, there was no delay in diagnosis and no re-biopsy necessary.After evaluation of the information available, it was found that the root cause of the issue was user related.The incorrect threshold settings were used, and the reagent alcohols were found to be contaminated due to infrequent reagent changes.After replacement of the contaminated reagent alcohols, and setting of the correct threshold levels, the instrument was working according to factory specifications.The responsible leica biosystems field service engineer carried out additional training measures at the customer site, highlighting the importance of maintaining a good ethanol gradient during the reagent exchange process.The instrument has been returned to clinical use and the customer has confirmed that no more processing issues have been observed.

• Common Device Name: PROCESSOR, TISSUE, AUTOMATED
• 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 ; heidelbergerstrasse 17-19; nussloch 69226 ; GM 69226 ; 6224143345
• MDR Report Key: 19069646
• Report Number: 8010478-2024-00009
• Device Sequence Number: 6966710
• Product Code: IEO
• UDI-Device Identifier: 04049188217769
• UDI-Public: (01)04049188217769(11)221212
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HISTOCORE PEGASUS PLUS
• Device Catalogue Number: 14048858007
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown