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

Model Number 7887-050

Device Problems Corroded (1131); Unintended System Motion (1430); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 02/05/2022

Event Type  malfunction  

Event Description

It was reported that the levó arm moved on its own in the middle of the surgery.

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
• Type of Device: 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
• MDR Text Key: 308069084
• Report Number: 2921578-2022-00023
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430104992
• UDI-Public: 00842430104992
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2921578-10/16/2019-001-R
• Patient Sequence Number: 1