MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B. V. PHILIPS ULTRA FAST SCANNER; WHOLE SLIDE IMAGING SYSTEM

Model Number UFS 1 SERIES

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2019

Event Type  malfunction  

Event Description

At the university of (b)(6) we are in the process of adopting whole slide scanning using the fda approved philips platform (philips intellipath system) for primary sign-out in pathology.Our goal is to go fully digital by the end of 2019.The scanning facility with sufficient number of scanners, the network, and storage are all in place.We established several working groups with faculty, trainees, and staff to assist the transition.Validation for subspecialty sign out is ongoing and 4 services (kidney, lung, bone and soft tissue, heart) are already on a fully digital platform.As part of the subspecialty validation for the breast service we noticed that the scanning fidelity (i.E., congruence between glass slide content and digital image content) was subpar in a significant proportion of mastectomy cases.Therefore, we decided to conduct a larger scale study to address the magnitude of this issue.In brief, digital images missed a significant proportion of tissues present in 38% of the glass slides.We informed philips about the findings and sent all the test slides (along with data) to (b)(6) to confirm.As a potential solution, we recommended philips to consider changing the scanning mode from the "standard" one that is scanning only tissues detected by an algorithm to one that is scanning the entire area of the glass slide for cases at risk, such as mastectomies with high adipose tissue content.Since our slides are barcoded, the scanner can easily recognize which type of specimens it is dealing with; based on a customized algorithm, the scanner will either scan the slides in a "standard" fashion, or "full face" mode.The full face scanning mode will result in larger size image files and will slow down scanning; however, it will improve subpar scanning fidelity observed with the standard set up.We are also in the process of conducting two add'l validation trials with highly fragmented tissues of gynecological and neuropathology specimens.Fda safety report id# (b)(4).

• Brand Name: PHILIPS ULTRA FAST SCANNER
• Type of Device: WHOLE SLIDE IMAGING SYSTEM
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B. V.
• MDR Report Key: 8596202
• MDR Text Key: 144692691
• Report Number: MW5086489
• Device Sequence Number: 2
• Product Code: PSY
• UDI-Device Identifier: 00884838085640
• UDI-Public: (01)00884838085640
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UFS 1 SERIES
• Device Lot Number: 4522 010 50002
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other