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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 3080 SURGICAL TABLE
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STERIS CORPORATION - MONTGOMERY 3080 SURGICAL TABLE Back to Search Results
Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/08/2014
Event Type  No Answer Provided  
Event Description
The user facility reported that an operator tried articulating the table via the hand control during a patient procedure and the table would not respond.The operator utilized the table's manual override controls and the procedure was completed successfully.No injuries or procedural delays/cancellations were reported.
 
Manufacturer Narrative
A steris service technician inspected the table and found three out of the four table feet were out of adjustment.The technician replaced the feet, tested the table and returned it to service.The table was remanufactured in 2013 and is under steris warranty.Steris is replacing the surgical table subject of the reported event with a new table.
 
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Brand Name
3080 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
kathryn cadorette
5960 heisley road
mentor, OH 44060
4403927231
MDR Report Key4064342
MDR Text Key17275826
Report Number1043572-2014-00090
Device Sequence Number1
Product Code FQO
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 09/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/08/2014
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 Number1
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