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U.S. Department of Health and Human Services

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

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STERIS CORPORATION - MONTGOMERY FOOT TRACTION BOOT TO ORTHOVISION TABLE Back to Search Results
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.
 
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Brand NameFOOT TRACTION BOOT TO ORTHOVISION TABLE
Type of DeviceFOOT 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 Key7627378
MDR Text Key112188920
Report Number1043572-2018-00050
Device Sequence Number1
Product Code JEB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received06/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/25/2018
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

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