MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA ASP300 S

Catalog Number 14047643514

Device Problem Insufficient Information (3190)

Patient Problem Tissue Breakdown (2681)

Event Date 08/14/2023

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 16 august 2023 leica biosystems received a complaint that the customer experienced suboptimal tissue processing on their leica asp300s.On 24 august 2023 the customer informed leica biosystems, that as a result, 4 biopsy samples could not be diagnosed.

Manufacturer Narrative

The investigation revealed the following: during the initial visit to the customer by a leica field service engineer, a logfile analysis was carried out that identified errors (65 and 66) relating to the retort thermometer in the service log at around the date of suspected run as a possible root cause of the incident.A more in depth examination of the instrument identified the overall age of the instrument, in particular the aging electronics system as the main contributor to the malfunction of the instrument.On a subsequent visit to the customer by a leica field service engineer the faulty thermometer and associated parts were replaced by standard spare parts.Because the age of the instrument had been identified as the main contributing factor to the malfunction of the instrument- at the time of the incident it had been more than 8 years in the field - it was decided carry out an overhaul of the entire electronics system of the device concerned.After sucessfully passing final pressure and vacuum tests and a verification test by the customer, the instrument has been returned to regular use without any further issues reported at this time.Considering that this was a single case occurance issue no further actions in the field are required to be carried out.

• Brand Name: LEICA ASP300 S
• Type of Device: LEICA ASP300 S
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; nussloch, 69226 ; GM 69226
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 17797785
• MDR Text Key: 324016189
• Report Number: 8010478-2023-00010
• Device Sequence Number: 1
• Product Code: IEO
• UDI-Device Identifier: 04049188055972
• UDI-Public: (01)04049188055972
• 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: 10/27/2023

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: 14047643514
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/27/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other