MAUDE Adverse Event Report: HAMAMATSU PHOTONICS K.K, SYSTEMS DIVISION, NANOZOOMER S360 (THIS IS AN IVDD PRODUCT, NOT SOLD IN THE U.S.); Whole slide imaging system

Model Number C13220-01

Device Problem Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2023

Event Type  malfunction  

Event Description

A malfunction of hamamatsu photonics k.K's (hamamatsu) nanozoomer s360 ivdd occurred in the united kingdom (uk).The nanozoomer s360 ivdd is a ce marked device compliant with the european union's in vitro diagnostics directive (ivdd).It is similar to the nanozoomer s360md slide scanner system, which is marketed in the united states (k213883).Although this incident did not occur in the united states, and the nanozoomer s360 ivdd is not marketed in the united states, the devices are similar.Out of an abundance of caution, we decided to submit mdr.There have been two instances in the uk where the scanning-technician customer scanned a slide, and due to the barcode label on the slide not being correctly printed, the file was given only a date and a time stamp as the filename.For example: the file name assigned to a scan on (b)(6)2023 at 9:30:05 was (b)(6)2023.When looking at the reference information on the scanner software application (nzacquire), however, when the scanning-technician opened the image (ndpi file) on the viewer software application and viewed the metadata (reference information), the reference field included the reference data from the previous slide in the scanning rack.If the wrong barcode information is recorded in the ndpi file, a pathologist may refer to the whole slide image (wsi) of a different patient.In other words, a different patient's scan may be attributed to the relevant patient.Hamamatsu has determined that this is caused by a software issue that is also present in the nzacquiremd software used with the nanozoomer s360md slide scanner system in the united states.As a precautionary measure, there are already two kinds of risk mitigations in place to reduce the potential serious risk.1.There is a clear note in the nzacquire reference manual regarding the barcode information.2.There is a warning in the system manual that the intended use of wsi generated out of the system is designed to provide information as an aid for a diagnosis among other information available.In other words, medical decisions should not be made exclusively based on the data from the device: the temporary measure taken: until the correction action has taken place, the affected users will perform one temporary measure to the software settings.The correction action taken: the risk of recurrence will be fully eliminated by conducting the nzacquiremd software update on the user pcs either through remote access or on-site by a field service engineer.

Manufacturer Narrative

The risk of recurrence will be fully eliminated by conducting the nzacquiremd software update on the user pcs by the end of june either through remote access or on-site by a field service engineer.

• Brand Name: NANOZOOMER S360 (THIS IS AN IVDD PRODUCT, NOT SOLD IN THE U.S.)
• Type of Device: Whole slide imaging system
• Manufacturer (Section D): HAMAMATSU PHOTONICS K.K, SYSTEMS DIVISION,; 812 joko-cho,; higashi-ku,; hamamatsu city,, shizuoka prefecture, 431-3 196; JA 431-3196
• Manufacturer (Section G): HAMAMATSU PHOTONICS K.K.; 812 joko-cho,; higashi-ku,; hamamatsu city,, shizuoka prefecture, 431-3 196; JA 431-3196
• Manufacturer Contact: shinichi fujisaka ; 812 joko-cho,; higashi-ku,; hamamatsu city,, shizuoka prefecture, 431-3-196 ; JA 431-3196
• MDR Report Key: 17067293
• MDR Text Key: 317664149
• Report Number: 0009614683-2023-00001
• Device Sequence Number: 1
• Product Code: PSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C13220-01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1