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 02/21/2023

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 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.

Manufacturer Narrative

Correction: the "establishment name" was incorrect in the initial report.The "establishment name" is "laboratoire kowalski gringnon depardieu".

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).

Manufacturer Narrative

Additional information: added unique identifier (udi) # in d4.

• 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: 16654404
• MDR Text Key: 312407650
• Report Number: 8010478-2023-00003
• Device Sequence Number: 1
• Product Code: IEO
• UDI-Device Identifier: 04049188217769
• UDI-Public: (01)04049188217769
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 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
• 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: 03/03/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 06/13/2023; 06/13/2023; 06/13/2023
• Supplement Dates FDA Received: 06/19/2023; 06/21/2023; 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other