MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. HANA TABLE; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES

Catalog Number 6875

Device Problem Malposition of Device (2616)

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

Event Date 12/08/2016

Event Type  malfunction  

Event Description

After intubation for surgery, the patient's right leg began to slip from hana table.Anesthesiologist and or staff present found it necessary to carefully lower patient to the floor.According to staff interviewed, the patient was heavy set ((b)(6) kgs) with weight mostly in the mid-section.Boots in hana bed was still not in place.Needed more than two staff to secure patient in hana bed.

Manufacturer Narrative

The following elements have blank data: unique device identifier (udi): for type of device: table, surgical with orthopedic accessories.

Event Description

After intubation for surgery, the patient's right leg began to slip from hana table.Anesthesiologist and or staff present found it necessary to carefully lower patient to the floor.According to staff interviewed, the patient was heavy set (b)(6) with weight mostly in the mid-section.Boots in hana bed was still not in place.Needed more than two staff to secure patient in hana bed.

• Brand Name: HANA TABLE
• Type of Device: TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave.; union city CA 94587
• MDR Report Key: 6303585
• MDR Text Key: 66586825
• Report Number: 6303585
• Device Sequence Number: 1
• Product Code: JEB
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2016,01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6875
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR