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

Model Number	7887-050
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported nearing the end of the procedure the levo arm gave out and was completely limp/moveable without pressing either button.
Event or Problem Description
It was reported nearing the end of the procedure the levo arm gave out and was completely limp/moveable without pressing either button.
Additional Manufacturer Narrative
There was no evidence of fluid ingress in this units.The corrosion on the contacts was most likely due to the sealant which creates a corrosive byproduct while it is curing.Updated design to eliminate the connectors, replaced the sealing compound curing and applied additional sealing to connectors.

• Brand Name: LEVO ARM
• Common Device Name: HEAD POSITIONING
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city, ca CA 94587 1234
• MDR Report Key: 9247202
• Report Number: 2921578-2019-00038
• Device Sequence Number: 2600294
• Product Code: JEA
• UDI-Device Identifier: 00842430104992
• UDI-Public: 00842430104992
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

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: 10/29/2019
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 03/16/2020
• 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