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

Model Number 7887-050

Device Problems Electrical Shorting (2926); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2019

Event Type  malfunction  

Event 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.

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 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 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.

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
• Type of Device: HEAD POSITIONING UNIT
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 8591692
• MDR Text Key: 145619904
• Report Number: 2921578-2019-00019
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430104992
• UDI-Public: 00842430104992
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• 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: 05/14/2019
• Date Manufacturer Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2921578-10/16/2019-R
• Patient Sequence Number: 1