MAUDE Adverse Event Report: PHILIPS VOLCANO INTRASIGHT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 797403

Device Problem Sharp Edges (4013)

Patient Problem Abrasion (1689)

Event Date 05/27/2022

Event Type  Injury  

Manufacturer Narrative

This case was reviewed and investigated according to the manufacturer¿s policy.The account decided that service is not required at this time; therefore, the monitor has not been replaced.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

Event Description

It was reported that the intrasight system's touchscreen monitor was cracked with sharp edges, resulting in a minor finger abrasion of the user.No medical intervention was required for the finger abrasion.The account placed tape over the cracked edge to put the system back into use.This adverse event and product problem is being reported due to the cracked touchscreen monitor with sharp edges, resulting in a minor finger abrasion of the user.

• Brand Name: INTRASIGHT
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): PHILIPS VOLCANO; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer (Section G): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer Contact: paulette nicole montes ; 3721 valley centre drive #500; san diego, CA 92130
• MDR Report Key: 14800621
• MDR Text Key: 295041117
• Report Number: 3008363989-2022-00050
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00845225012878
• UDI-Public: (01)00845225012878(90)300000437313
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 797403
• Device Catalogue Number: 797403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2019
• 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
• Patient Outcome(s): Other