MAUDE Adverse Event Report: TOSHIBA-CANON MEDICAL SYSTEMS USA, INC. TOSHIBA-CANON INFINIX- 1; INTERNATIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number DETECTOR SOFT COVER

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 10/22/2018

Event Type  Injury  

Event Description

This is a (b)(6) female who has a known history of (b)(6).She has undergone (b)(6) treatment.She has been followed and found to have an enlarging lesion in the right posterolateral portion of the right lobe of the liver.This lesion underwent biopsy.On standing the patient up, she became orthostatic and tachycardic and there was concern about post biopsy bleeding.The patient went for a stat cta where there was seen to be some extravasation and she then went for a stat arterial embolization.During an interventional radiology procedure, the image intensifier in the interventional suite lowered down and touched the patient¿s abdomen.Normally, upon touching the patient, the device then has a sensor that functions and has the image intensifier raise up from touching the patient.This day, the sensor did not work and the image intensifier stayed against the patient causing her some pain.The image intensifier was immediately lifted off the patient by the radiology tech standing next to her.The maintenance company was called and the part was replaced.

• Brand Name: TOSHIBA-CANON INFINIX- 1
• Type of Device: INTERNATIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): TOSHIBA-CANON MEDICAL SYSTEMS USA, INC.; tustin CA 92780
• MDR Report Key: 8142323
• MDR Text Key: 130029354
• Report Number: MW5081940
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/04/2018

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 Model Number: DETECTOR SOFT COVER
• Device Catalogue Number: BX14-1175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2018
• 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 Age: 64 YR
• Patient Weight: 93