MAUDE Adverse Event Report: SKYTRON, LLC 6500 ELITE; TABLE, SURGICAL

Device Problems Device Inoperable (1663); Positioning Problem (3009)

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

Event Date 04/29/2016

Event Type  malfunction  

Event Description

Two buttons on the operating room table didn't work for reflex positioning for knee case.Optimal position not reached.This is an old device no longer supported by manufacturer.

• Brand Name: 6500 ELITE
• Type of Device: TABLE, SURGICAL
• Manufacturer (Section D): SKYTRON, LLC; 5085 corporate exchange blvd. se.; grand rapids MI 49512
• MDR Report Key: 6053619
• MDR Text Key: 58275381
• Report Number: 6053619
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 09/30/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24 YR