MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE PEGASUS PLUS

Catalog Number	14048858007
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	02/21/2023
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 21 february 2023 leica biosystems received a complaint that the customer experienced suboptimal tissue processing on their histocore pegasus plus.On 03 march 2023 the customer informed leica biosystems, that as a result, 1 tissue skin sample has not been diagnosed.
Additional Manufacturer Narrative
Correction: the "establishment name" was incorrect in the initial report.The "establishment name" is "laboratoire kowalski gringnon depardieu".
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 related to the damaged tissue.Furthermore, the affected instrument was sent back to nussloch for an additional investigation with result, that no malfunction of the instrument has been found.The incident was user related due to an incorrect usage of the processing protocol and carryover settings, because the tissues and biopsies were processed together with an overnight protocol.The carryover setting is a setting for a protocol, not for a specific run, so it must be set to the average carryover value for runs that use that protocol.The carryover is dependent on the types of cassettes and other small-tissue carriers used: biopsy pads, paper or tissue inserts, mini cassettes, biopsy cassettes, etc.It also depends on the proportion of these in each run.Therefore, the protocol setup depends on the processed tissues, and therefore different protocol and carryover settings need to be selected.A customer facing letter will be sent out to the customer with recommendation, to consider the carryover setting and to use the recommended accordingly the protocol for standard biopsy and small specimen as defined in the instruction for use (ifu).
Additional Manufacturer Narrative
Additional information: added unique identifier (udi) # in d4.

• Brand Name: HISTOCORE PEGASUS PLUS
• Common Device Name: HISTOCORE PEGASUS PLUS
• 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: 16654404
• Report Number: 8010478-2023-00003
• Device Sequence Number: 6616563
• Product Code: IEO
• UDI-Device Identifier: 04049188217769
• UDI-Public: (01)04049188217769
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,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: 14048858007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 06/13/2023; 06/13/2023; 06/13/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 06/19/2023; 06/21/2023; 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown