MAUDE Adverse Event Report: AMATECH SKYTRON; LEVITATOR STIRRUP

Catalog Number 4-090-03-1

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2015

Event Type  Injury  

Event Description

During a surgical case, a patient's leg was in a levitator stirrup when the stirrup spring upwards.No injuries were reported.Staff held the stirrup in place and the surgery was able to be completed.The facility is returning the stirrup to skytron for further evaluation.

• Brand Name: SKYTRON
• Type of Device: LEVITATOR STIRRUP
• Manufacturer (Section D): AMATECH; acton MA
• Manufacturer (Section G): SKYTRON, DIV. THE KMW GROUP, INC.; 5000 36th st., s.e.; grand rapids MI 49512
• Manufacturer Contact: 5000 36th st., s.e.; grand rapids, MI 49512
• MDR Report Key: 5130881
• MDR Text Key: 27690947
• Report Number: 1825014-2015-00044
• Device Sequence Number: 1
• Product Code: EYD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4-090-03-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2015
• Distributor Facility Aware Date: 09/02/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 62