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

MAUDE Adverse Event Report: STERIS CORP. STERIS OT-1100 FRACTURE TABLE TABLE, SURGICAL

  • 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 CORP. STERIS OT-1100 FRACTURE TABLE TABLE, SURGICAL Back to Search Results
Device Problems Break (1069); Self-Activation or Keying (1557); Unintended Movement (3026)
Patient Problem No Information (3190)
Event Type  No Answer Provided  
Event Description
An orthopedic surgeon was utilizing a steris ot-1100 fracture table during a surgical procedure. Prior to commencing the surgery, the fracture table had been set to the height and angle requested by the surgeon. During the surgery, the fracture table tilted downward at the lower end of the table. None of the surgery personnel witnessed the movement of the table. Adjustments to the height and position of the table are made using the handheld control which is attached to the table via cord. None of the personnel were operating the handheld control at the time of the incident. The device manufacturer was contacted and sent a service technician to inspect the fracture table. After a thorough inspection, no issues were identified which would have resulted in movement of the table (i. E. Hydraulic leak). The service technician could not get the fracture table to repeat the incident during his inspection. It was noted that the handheld control showed some damage. The handheld remote was replaced prior to placing the fracture table back in service.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTERIS OT-1100 FRACTURE TABLE
Type of DeviceTABLE, SURGICAL
Manufacturer (Section D)
STERIS CORP.
MDR Report Key7199595
MDR Text Key97715670
Report NumberMW5074597
Device Sequence Number1
Product Code JEB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-