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

Catalog Number 14048858007

Device Problem Insufficient Information (3190)

Patient Problem Tissue Breakdown (2681)

Event Date 07/18/2023

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 (b)(6) 2023 leica biosystems received a complaint that the customer experienced suboptimal tissue processing on their histocore pegasus plus.On (b)(6) 2023 the customer informed leica biosystems, that as a result, 1 breast core bx sample has not been fully diagnosed.

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.The instrument is working according to factory specifications.The incident was user related and caused by the fixation and usage of the incorrect assignment of the carryover value setting for created or edited protocols.If the setup of carryover is lower than the actual carryover, it may potentially cause tissue damage (mainly under-processed tissue).A customer letter was 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).

• 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: 17754382
• MDR Text Key: 323471180
• Report Number: 8010478-2023-00009
• Device Sequence Number: 1
• Product Code: IEO
• UDI-Device Identifier: 04049188217769
• UDI-Public: (01)04049188217769
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/23/2023

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
• 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: 08/17/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 10/25/2023
• Supplement Dates FDA Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2022
• 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
• Patient Age: 67 YR
• Patient Sex: Female