MAUDE Adverse Event Report: MIZUHO SKYTRON; SURGICAL TABLE

Model Number 3500

Device Problem Unintended Head Motion (1284)

Patient Problem No Information (3190)

Event Date 07/01/2014

Event Type  malfunction  

Event Description

During surgery, the head section of the table dropped.Pt is being evaluated for injury and extent is unk at time of filing.

Manufacturer Narrative

At this time we have not been able to determine the extent of the injury to the pt.The table was examined by a biomedical engineer who reported that the ball and socket joint on the trend cylinder came apart.

• Brand Name: SKYTRON
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): MIZUHO; tokyo ; JA
• MDR Report Key: 4309866
• MDR Text Key: 5209110
• Report Number: 1825014-2014-00010
• Device Sequence Number: 1
• Product Code: GDC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3500
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/01/2014
• Device Age: 19 YR
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1