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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 3085 SURGICAL TABLE
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STERIS CORPORATION - MONTGOMERY 3085 SURGICAL TABLE Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/22/2014
Event Type  No Answer Provided  
Event Description
The user facility reported that after a patient procedure was completed the table was being moved into the hallway and an oil trail was noticed.No injuries or procedural delays/cancellations were reported.
 
Manufacturer Narrative
A steris service technician inspected the table and found a hole in the hydraulic pressure supply hose.The technician stated that the hole in the hose could be attributed to the hose rubbing on the base of the table column.The technician replaced the hose and confirmed the table to be operational.No additional issues have been reported.
 
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Brand Name
3085 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 Key4025270
MDR Text Key17631486
Report Number1043572-2014-00080
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 08/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2014
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 Received07/22/2014
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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