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

Catalog Number 14048858007

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/04/2023

Event Type  Injury  

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 Description

On 06 december 2023 leica biosystems received a complaint that the customer experienced suboptimal tissue processing on their histocore pegasus plus.As a result, 6 samples needed to be recollected.

Manufacturer Narrative

The investigation revealed the following: based on the investigation, the biópsia" protocol started at 19:53, (b)(6) 2023, in which tissue slides of 6 patients read with blue hue and diffused nucleus meltdown, and the block description with "soft and can't flat at the mold bottom" symptom reported by the end user indicated that paraffin didn't infiltrate well into the cell, i.E., under processing.Nucleus meltdown could possibly be caused by: 1) the water in the tissue cells wasn't fully replaced by water-based solvent (formalin), so the enzyme wasn't stopped to meltdown the nucleus; or 2) fixation reagent in the tissue processor was contaminated, causing the nucleus to melt down.But according to the log, the affected program ran 1 min only in s2, so the impact from this cause for this case could be minimal.This leads to the potential cause that the water in the tissue cells was not fully replaced by formalin before the protocol started.The end user could not offer the fixation tracking record to confirm or to rule out this cause.Furthermore, 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 be possibly caused by the following 3 reasons: 1) faulty step of processing, however, the evidence of the log shows that each step of the protocol has been executed with planned time.2) over threshold reagent, however, the evidence of the log shows that the reagent change is within the threshold range.3) cross contamination in reagent bottle.The cross contamination could be caused by the following 3 reasons: a) the reagent bottle(s) is filled to a level exceeding the maximum line, causing the extra reagent to enter other reagent stations, however, the customer reported that they did not overfill the reagent bottles.B) the extra reagent can be carried over from grossing to the reagent bottles of the tissue processor via the tissue basket and biopsy filter paper and can accumulate over time.The carryover amount could be increased if the operator does not allow some time to drain the tissue baskets when transferring from grossing.Additionally, if the operator does not timely clear the excessive reagent in the reagent bottle(s), it could cause the extra reagent entering other reagent stations.C) the filter paper used to wrap biopsy tissues was not standardized and some were excessively big and folded with many layers, which would cause some excessive carryover during processing.A customer facing letter was sent out to the customer with recommendation, to consider the tissue fixation and to avoid reagent cross contamination.

• Brand Name: HISTOCORE PEGASUS PLUS
• Type of Device: 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: 18363126
• MDR Text Key: 330975475
• Report Number: 8010478-2023-00017
• Device Sequence Number: 1
• Product Code: IEO
• UDI-Device Identifier: 04049188217769
• UDI-Public: (01)04049188217769
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 02/02/2024

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 Operator: Health Professional
• Device Catalogue Number: 14048858007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 01/05/2024
• Supplement Dates FDA Received: 02/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2022
• 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