• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY ORTHO VISION SURGICAL TABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STERIS CORPORATION - MONTGOMERY ORTHO VISION SURGICAL TABLE Back to Search Results
Device Problem Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/19/2017
Event Type  malfunction  
Manufacturer Narrative
During the time of the reported event, the table top was level and the patient was secured to the table with restraints and coban tape. User facility personnel heard a "pop" sound as the patient's torso began to shift to the left side of the table. The patient was repositioned on the table and the procedure was completed successfully as no delays or cancellations were reported. A steris service technician arrived onsite to inspect the ortho vision table and found the table to be operating per specifications. The technician confirmed there was no evidence of any hydraulic leaks and did not note any issues with the operation of the table's tilt and lateral translations. The ortho vision table is not under a steris service contract and is maintained by a third-party service provider. In-service training was scheduled for 4/25/2017 however the user facility requested that steris reschedule. Steris account manager has made multiple attempts to reschedule in-service training on the proper use and maintenance of the table with the facility and the facility has not responded.
 
Event Description
The user facility reported that during a patient procedure, they heard a "popping" noise and the ortho vision table moved without being commanded to do so. The patient did not sustain any injuries.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameORTHO VISION SURGICAL TABLE
Type of DeviceSURGICAL 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
kathryn cadorette
5960 heisley road
mentor, OH 44060
4403927231
MDR Report Key6576993
MDR Text Key75666444
Report Number1043572-2017-00030
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 05/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2017
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

-
-