MAUDE Adverse Event Report: HITACHI LTD, HEALTHCARE BUSINESS UNIT OASIS; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number	OASIS
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Issue (2379); Human Factors Issue (2948)
Health Effect - Clinical Codes	No Patient Involvement (2645); Patient Problem/Medical Problem (2688)
Date of Event	05/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oasis is a 1.2 tesla vertical field (open) mri system.The patient table has a movable top that is motorized and is used to position the patient within the magnet.Below the tabletop, there is a aluminum band in a recessed track that covers a chain drive.The band is only visible when the tabletop is extended into scanning position.The patient would never be in contact with this surface as the band is fully covered when the tabletop is retracted to the position where the patient is loaded/unloaded.When extended, the technologist brushed his finger across the band an caught it sufficiently to raise it out of the recessed area and allow the edge to cut his finger.This is the first report of this kind for the oasis product.
Event or Problem Description
The technologist was setting up a patient exam on the hitachi oasis mri system on (b)(6) 2017.During patient setup, the technologist went around the table end to speak with the patient.The table was set up for a lumbar study, and his finger was cut by the metal tape that runs down the center of the table.The table wasn't in motion, he just touched the metal tape without realizing tape is sharp.Initially he didn't feel anything, until he noticed the blood.The technologist confirmed on 6/12/2017 that he went to urgent care and got 4 stitches and was prescribed an antibiotic.

• Brand Name: OASIS
• Common Device Name: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): HITACHI LTD, HEALTHCARE BUSINESS UNIT; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• MDR Report Key: 6641531
• Report Number: 8030405-2017-00002
• Device Sequence Number: 981400
• Product Code: LNH
• UDI-Device Identifier: 04580292768186
• UDI-Public: (01)04580292768186(11)160823(250)G210059416
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K093044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date (Section B): 05/15/2017

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
• Operator of Device: Radiologic Technologist
• Device Model Number: OASIS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 06/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Weight: 91