MAUDE Adverse Event Report: MIZUHO SKYTRON 3602 ULTRA SLIDE TABLE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 3602

Device Problem Unintended System Motion (1430)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

The authorized service representative visited the facility on (b)(6) 2020 and performed an evaluation.He reported back to the facility that "the table was inspected thoroughly and no signs of malfunction could be found.The leg section was operating correctly and the auxiliary switches were operating correctly as well.The hand pendant in question operated correctly with the table.The second hand pendant operated correctly with the table.Then initial hand pendant that was removed will be sent to skytron for further testing and we will provide an update asap." the pendant control was evaluated at skytron on 11/30/2020.The reported issue of leg down movement could not be duplicated.The skytron evaluation identified physical damage to the control shown in the customer photos and added that the cannon connector appeared to have been incorrectly attached to the table at some point.This is not believed to be related to the failure.Skytron provided this update to the authorized representative who shared with the facility that skytron was unable to duplicate the failure and that the pendant is being returned to the manufacturer for their evaluation.The pendant has been returned to the manufacturer.We await the results of their evaluation.

Event Description

On (b)(6) 2020 skytron became aware of an alleged device malfunction reported by a skytron authorized service representative.The representative reported that the facility contacted him stating the leg section of the operating table moved in leg down without the leg down butting initially being pressed.A patient was on the table at the time.No injury was reported.

• Brand Name: SKYTRON 3602 ULTRA SLIDE TABLE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MIZUHO; 3-30-13 hungo, bunkyo-ku; tokyo, 113-0 033; JA 113-0033
• MDR Report Key: 10992781
• MDR Text Key: 223373282
• Report Number: 1825014-2020-00019
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2020
• Distributor Facility Aware Date: 12/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1