MAUDE Adverse Event Report: MIZUHO OSI LEVÓ ARM; HEAD/NECK POSITIONER

Model Number	7887-050
Medical Device Problem Codes	Corroded (1131); Unintended System Motion (1430); Device Slipped (1584)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the levó arm moved on its own in the middle of the surgery.
Additional Manufacturer Narrative
Upon investigation and evaluation of the returned unit to the manufacturer, it was found that the likely cause of undesired movement of the levó arm is due to the outgassing of rtv sealant compound applied within the device.The penetration of the outgas into the connector contact cavity lead to the corrosion and shorting of internal pin connection thus leading to failure of the brake and unwanted motion of the unit.The incident was initially assessed as not-reportable.Following investigation and evaluation of the device, the incident was reassessed to be reportable.After several attempts of communication with the hospital personnel, no information was obtained regarding the patient and their health status.A recall is currently in progress for the levó arm, ref # (b)(4).

• Brand Name: LEVÓ ARM
• Common Device Name: HEAD/NECK POSITIONER
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 3003 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 15777246
• Report Number: 2921578-2022-00023
• Device Sequence Number: 6675834
• Product Code: JEA
• UDI-Device Identifier: 00842430104992
• UDI-Public: 00842430104992
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7887-050
• Device Catalogue Number: 7887-050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2921578-10/16/2019-001-R
• Patient Sequence Number: 1
• Patient Sex: Unknown