MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. WILSON PLUS; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

Catalog Number 5322PV

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/27/2018

Event Type  malfunction  

Event Description

Arm pads/sponges (foam arm cradle) do not decompress.They stay flat and are unable to be used.These arm pads/foam arm cradle come in the wilson frame care kit 5322pv.

• Brand Name: WILSON PLUS
• Type of Device: TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587
• MDR Report Key: 7619509
• MDR Text Key: 111704985
• Report Number: 7619509
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5322PV
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR