PHILIPS ULTRA FAST SCANNER UFS 1 SERIES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-09 for PHILIPS ULTRA FAST SCANNER UFS 1 SERIES manufactured by Philips Electronics Nederland B. V..

Event Text Entries

[144692691] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5086489
• MDR Report Key: 8596202
• Date Received: 2019-05-09
• Date of Report: 2019-05-06
• Date of Event: 2019-04-24
• Date Added to Maude: 2019-05-09
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: PHILIPS ULTRA FAST SCANNER
• Generic Name: WHOLE SLIDE IMAGING SYSTEM
• Product Code: PSY
• Date Received: 2019-05-09
• Model Number: UFS 1 SERIES
• Lot Number: 4522 010 50002
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PHILIPS ELECTRONICS NEDERLAND B. V.

Device Sequence Number: 2

• Brand Name: PHILIPS ULTRA FAST SCANNER
• Generic Name: WHOLE SLIDE IMAGING SYSTEM
• Product Code: PSY
• Date Received: 2019-05-09
• Model Number: UFS 1 SERIES
• Lot Number: 4522 010 50002
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: PHILIPS ELECTRONICS NEDERLAND B. V.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-05-09