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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY OT 1100 SURGICAL TABLE
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STERIS CORPORATION - MONTGOMERY OT 1100 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 10/02/2014
Event Type  No Answer Provided  
Event Description
The user facility reported that during a patient procedure traction could not be applied to the table; the procedure was subsequently cancelled.No injuries were reported.
 
Manufacturer Narrative
A steris service technician inspected the table and found the right t-handle wing nut on the leg spar was stripped.The technician replaced the wing nut and returned the table to service.No additional issues have been reported.The t-handle wing nut was returned to steris and will be evaluated.
 
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Brand Name
OT 1100 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 Key4218013
MDR Text Key4968645
Report Number1043572-2014-00112
Device Sequence Number1
Product Code JEA
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 10/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 10/02/2014
Initial Date FDA Received10/31/2014
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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