MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE PEGASUS

Catalog Number 14048858005

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, the complainant contacted leica and detailed: "retort a tissue over processed, slides nuclear details are gone.User suspecting some type of reagent contamination, carry over issue.Hydrometer check performed, all reagents are within limits.No reagents changed.Retort b tissue was fine, and it was running at an hour apart, same protocol, same type of tissue." the lab has changed all the reagent including wax.They ran test runs on retort a ( 4 cassettes) and retort b (1 cassette), all tissue processed as it should.They will be running more tests.They are seeing nuclear meltdown with 150 specimens affected.They have requested an fse on site before they begin to use the processor again.On 20 december 2023, leica biosystems nussloch received the following information provided by the histology technical specialist - canada to the leica biosystems shanghai quality engineer: "diagnosis was made for all cases however 1 prostate case ( 18 cassettes) was impacted to the degree in which one patient will require a repeat biopsy.".

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.

Manufacturer Narrative

The investigation revealed the following: based on the investigation, the "routine overnight"" protocol in retort a started at 10:35am,(b)(6) 2023, which has 1 prostate case (18 cassettes) read with diffused nucleus meltdown reported by the end user indicated that paraffin didn't infiltrate well into the cell.The reagent was exchanged after the incident and no firsthand evidence.Here is the possible root cause by the information that were available, while the final root cause can't be determined, because the affected run reagent status was not available.The slides reading shows diffused nuclear meltdown which has the phenomenon of serious blue hue which means paraffin didn't infiltrate well into the cell, indicating the tissue had insufficient dehydration and clearing, and the clearing solvent was not replaced with wax.This could possibly be caused by the following 4 reasons of reagent contamination: a.Overfilled reagent/paraffin: if the customers have the behavior to top up the reagent bottle/paraffin bath with excess reagent/paraffin above the maximum line, the excess reagent/paraffin has the risk to jump into the other stations and result in the reagent contamination.However, the customer reported that they did not overfill the reagent bottles.B.High carryover volume of carrier material: some types of biopsy carrier material have the large carryover volume, which may increase the reagent level and further increase the risk of the excess reagent into other stations to cause contamination.C.No drip action before adding the basket into the retort: the baskets filled with cassettes after the grossing process have the carryover volume of formalin.If the formalin was not dripped out from the basket before adding it into the retort, which could also cause the higher level of reagent above the max line, then it will have the risk to cause reagent contamination.D.Cleaning molds during the cleaning protocol: according to the description from fas, the customers have the behavior to clean molds during the cleaning protocol.Although cleaning reagents were in the recommended 10 cycles, however, customers always clean the molds during the cleaning protocol, which would get the cleaning reagents dirty in less usage and affect the cleaning effectiveness.Then, the retort cannot be cleaned completely and the reagent or wax residuals in the liquid system will get into the next processing run, which can cause the contaminated reagents.According to instruction for use: run cleaning protocol to clean additional materials other than baskets has the risk to impair the samples.A customer facing letter was sent out to the customer with recommendation, how to avoid reagent cross contamination.

• Brand Name: HISTOCORE PEGASUS
• Type of Device: HISTOCORE PEGASUS
• 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: 18387677
• MDR Text Key: 331293187
• Report Number: 8010478-2023-00018
• Device Sequence Number: 1
• Product Code: IEO
• UDI-Device Identifier: 04049188216397
• UDI-Public: (01)04049188216397
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 14048858005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male