MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. LEVO ARM; HEAD POSITIONING

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	05/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the levo arm was in use and locked while a patients head was connected to the skull clamp.The levo arm released and the patients head dropped without any release buttons being depressed.
Additional Manufacturer Narrative
The cause of the unintended motion was a short circuit of the control circuit due to fluid ingress.Fluid ingress path appears to have originated from around the upper release button at the control handle.This fluid caused a temporary short circuit.During inspection the fluid had dried out and the short circuit was not measurable.
Event or Problem Description
It was reported the levo arm was in use and locked while a patients head was connected to the skull clamp.The levo arm released and the patients head dropped without any release buttons being depressed.
Additional Manufacturer Narrative
The cause of the unintended motion was a short circuit of the control circuit due to fluid ingress.Fluid ingress path appears to have originated from around the upper release button at the control handle.This fluid caused a temporary short circuit.During inspection the fluid had dried out and the short circuit was not measurable.
Event or Problem Description
It was reported the levo arm was in use and locked while a patients head was connected to the skull clamp.The levo arm released and the patients head dropped without any release buttons being depressed.

• Brand Name: LEVO ARM
• Common Device Name: HEAD POSITIONING
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 8664256
• Report Number: 2921578-2019-00022
• Device Sequence Number: 2131016
• Product Code: JEA
• UDI-Device Identifier: 00842430104992
• UDI-Public: 00842430104992
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• 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?: Yes
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 08/09/2019; 08/09/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 08/16/2019; 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: 2921578-10/16/2019-001-R
• Patient Sequence Number: 1