MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY FOOT TRACTION BOOT TO ORTHOVISION TABLE

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Fall (1848)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

Based on the description on the event, it appears that the foot traction boot was not properly secured causing the reported event.As the doctor began to push down on the patient's foot the foot traction boot detached from the table causing the doctor to lose his balance and the patient's leg to lower in height.A steris service technician arrived onsite to inspect the orthovision table.While onsite, the technician found that the foot traction boot was not attached to the surgical table.The technician inspected the table and found it to be operating according to specification; no repairs were required.A steris account manager offered in-service on the proper use and operation of the orthovision surgical table and the user facility has accepted this offer.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure, the doctor began to push down on the foot traction boot attached to the othovision table when the boot came loose causing the doctor to fall backwards and the patient's leg to fall from the boot.No injuries to the doctor or patient were associated with the reported event.The procedure was completed successfully.

• Brand Name: FOOT TRACTION BOOT TO ORTHOVISION TABLE
• Type of Device: FOOT TRACTION BOOT TO ORTHOVISION 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: 7627378
• MDR Text Key: 112188920
• Report Number: 1043572-2018-00050
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2018
• 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