MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. LEVO ARM; HEAD/NECK PROCDURE POSITIONER

Model Number	7887-050
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The levo arm was being positioned preoperatively and full movement and function of the arm was not available.The ball joint articulation point immediately posterior to the release button and handle was not moving freely.The device was returned to the manufacturer for evaluation.Evidence of fluid ingress and corrosion was found failures with a potential to cause unexpected motion.
Additional Manufacturer Narrative
Conclusion of investigation: water ingress caused corrosion at connector, corrosion at gears and shorted the wrist joint motor.This created electrical and mechanical problems leading to the improper functions described by the customer.
Event or Problem Description
The levo arm was being positioned preoperatively and full movement and function of the arm was not available.The ball joint articulation point immediately posterior to the release button and handle was not moving freely.The device was returned to the manufacturer for evaluation.Evidence of fluid ingress and corrosion was found failures with a potential to cause unexpected motion.

• Brand Name: LEVO ARM
• Common Device Name: HEAD/NECK PROCDURE POSITIONER
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city, ca
• MDR Report Key: 9739065
• Report Number: 2921578-2020-00009
• Device Sequence Number: 13946786
• Product Code: JEA
• UDI-Device Identifier: 00842430104992
• UDI-Public: 00842430104992
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2020

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: 12/16/2019
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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