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	Insufficient Information (4580)
Date of Event	03/08/2024
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 08 march 2024, leica biosystems received a complaint that the customer experienced suboptimal tissue processing on their histocore pegasus plus, tissue processor.The customer informed leica biosystems, that as a result, 1 tissue sample have not been diagnosed.
Additional Manufacturer Narrative
The root cause of the issue, described as 'blocks being mushy, spongy, and smelling like xylene,' could not be unequivocally established from the information available.An investigation of this complaint found that the instrument functioned as designed and completed successfully during the period from (b)(6) to (b)(6), during which sub-optimal processing of patient tissue samples was reported by the complainant.There are some suspected points that cannot be confirmed with the limited information available: protocol too short for large tissue, incomplete wax infiltration, wrong wax concentrations, and excessive xylene-contaminated wax.1.Protocol too short for large tissue: the customer reported that the blocks are mushy, spongy, which is more likely indicative of under-processed tissues.We are aware that customers may use the same protocol to process tissues of varying sizes.However, it is unable to provide us with the size of the affected tissue, so this cause can only be suspected.2.Incomplete wax infiltration: blocks smell like xylene seems like poor wax infiltration due to insufficient time in wax.However, it is unable to provide us with the size of the affected tissue, so this cause can only be suspected.3.Wrong wax concentrations: customer reported blocks smell like xylene.The last wax step might contain more xylene than the gui indicates.However, the wax concentration cannot be measured on-site, so this cause can only be suspected.4.Excessive xylene-contaminated wax: customer reported blocks smell like xylene may be due to excessive xylene-contaminated wax.However, the wax concentration cannot be measured on-site, so this cause can only be suspected.

• 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: andreas helmstetter ; nussloch 69226 ; GM 69226 ; 6224143413
• MDR Report Key: 19056906
• Report Number: 8010478-2024-00008
• Device Sequence Number: 7949534
• Product Code: IEO
• UDI-Device Identifier: 04049188217769
• UDI-Public: (01)04049188217769(11)230801
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• 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): 10/10/2024

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 Catalogue Number: 14048858007
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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 Age: 7 YR
• Patient Sex: Unknown