MAUDE Adverse Event Report: MIZUHO CORPORATION SKYTRON; SURGICAL TABLE

Model Number 3603

Device Problems Improper or Incorrect Procedure or Method (2017); Noise, Audible (3273)

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

Event Date 07/03/2018

Event Type  malfunction  

Event Description

Customer put table into steep trend, head down and the table top made contact with the table base and in the process pressed the emergency stop button.The patient had to be moved to another table, no injuries were reported.Instructions and warnings are indicated throughout the operating manual.This table features an interlock system which sounds a continuous audible alarm and initially immobilizes the table to prevent occurrences such as this.The operator then has the option to continue lowering the table but visual care needs to be taken to prevent the table from colliding with itself.

• Brand Name: SKYTRON
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): MIZUHO CORPORATION; 2-27-17 hongo; bunkyo-ku; tokyo, japan ; JA
• MDR Report Key: 7769977
• MDR Text Key: 116706803
• Report Number: 1825014-2018-00020
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3603
• Device Catalogue Number: 3603
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other