MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. LEVÓ; HEAD POSITIONING UNIT

Model Number	7887-050
Medical Device Problem Codes	Electrical Shorting (2926); Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the levó arm was being cleaned following a case.Equipment tech noticed arm move without engaging light blue or dark blue buttons on pistol grip control during cleaning.Levó arm removed from dual motion base and noticed continued movement without engaging buttons.Clicking noise heard while pressing light blue and dark blue button individually on pistol grip.
Additional Manufacturer Narrative
There was insignificant amount of silicone applied to the back side of the dove tail block in the upper arm assembly.The poorly sealed area allowed cleaning solution to enter and eventually decayed the connector creating a corrosion bridge that shorted the wires.Once shorted, all the three joints and the ball joint remained open.The ball joint over heated and damaged the ball joint motor.
Event or Problem Description
It was reported the levó arm was being cleaned following a case.Equipment tech noticed arm move without engaging light blue or dark blue buttons on pistol grip control during cleaning.Levó arm removed from dual motion base and noticed continued movement without engaging buttons.Clicking noise heard while pressing light blue and dark blue button individually on pistol grip.
Event or Problem Description
It was reported the levó arm was being cleaned following a case.Equipment tech noticed arm move without engaging light blue or dark blue buttons on pistol grip control during cleaning.Levó arm removed from dual motion base and noticed continued movement without engaging buttons.Clicking noise heard while pressing light blue and dark blue button individually on pistol grip.
Additional Manufacturer Narrative
There was insignificant amount of silicone applied to the back side of the dove tail block in the upper arm assembly.The poorly sealed area allowed cleaning solution to enter and eventually decayed the connector creating a corrosion bridge that shorted the wires.Once shorted, all the three joints and the ball joint remained open.The ball joint over heated and damaged the ball joint motor.

• Brand Name: LEVÓ
• Common Device Name: HEAD POSITIONING UNIT
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 8591692
• Report Number: 2921578-2019-00019
• Device Sequence Number: 13971658
• Product Code: JEA
• UDI-Device Identifier: 00842430104992
• UDI-Public: 00842430104992
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2019

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: 05/14/2019
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 08/02/2019; 08/02/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 08/15/2019; 10/25/2019
• 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-R
• Patient Sequence Number: 1