MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY TRACTION BOOT ASSEMBLY TO OT1100 SURGICAL TABLE

Device Problem Device Slipped (1584)

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

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

A steris account manager arrived onsite and spoke with facility personnel about the reported event.Through follow-up with user facility personnel, it was determined that the reported event is attributed to user error as facility personnel did not properly place the traction boot disposable pads on the patient as stated in the instructions for use.The traction boot assembly instructions for use states, "warning - personal injury hazard and/or equipment damage hazard: read and understand all instruction presented in this document before using the traction boot assembly as directed within the traction boot assembly instructions for use." the instructions for use further states, "4.Place patient's foot in traction boot disposable pad." a steris account manager performed in-service training on the proper user and operation of the traction boot assembly, specifically properly placing the patient's foot in the traction boot disposable pad.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure a patient's foot slipped from the disposable pad within their traction boot assembly that was attached to their ot1100 surgical table.The procedure was completed successfully.No report of injury.

• Brand Name: TRACTION BOOT ASSEMBLY TO OT1100 SURGICAL TABLE
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 11514892
• MDR Text Key: 243812068
• Report Number: 1043572-2021-00014
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1