MAUDE Adverse Event Report: MIZUHO CORPORATION SKYTRON; 6700B

Model Number 6700B

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Self-Activation or Keying (1557); Smoking (1585); Device Tipped Over (2589); Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2017

Event Type  Injury  

Event Description

A 6700b table moved on its own during a case.On (b)(6) at approximately 12:30, the patient was on the table for approximately one half hour in the beach chair position doing a shoulder arthroscopy.Patient weight was (b)(6).The table started to trendelenburg without a control being hit, stopped, then started to trendelenburg again.The table then tilted and was out of control of staff.The staff tried to unplug the table to no affect, the table then stopped.Staff noticed smoke rising from under the control panel.Patient was transferred to a stretcher.Upon inspection from a skytron authorized service representative, the auxiliary control switch plate circuit board has been burnt and the connector melted.The table was being used for a surgery where fluids were being used.The fluid may have intruded below the switch plate cover and as a conductor made contact connection to the circuit board connection which may have energized some of the auxiliary switches and created the table movement until the solenoid coils burned out.The table has lost four functions due to solenoids not functioning.The table has been returned to skytron for further evaluation.(b)(4).No patient injuries were reported.Skytron has followed up with the original complainant regarding any possible patient involvement.Skytron has also followed up with the safety coordinator at the facility.No response as of 10/5/2017.

• Brand Name: SKYTRON
• Type of Device: 6700B
• Manufacturer (Section D): MIZUHO CORPORATION; 2-27-17 hongo; bunkyo-ku; tokyo 113, japan ; JA
• MDR Report Key: 6916943
• MDR Text Key: 88367405
• Report Number: 1825014-2017-00007
• 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: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6700B
• Device Catalogue Number: 6700B
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2017
• Distributor Facility Aware Date: 09/07/2017
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention