Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 4095 GENERAL 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 4095 GENERAL SURGICAL TABLE Back to Search Results
Device Problem Unintended System Motion (1430)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/10/2022
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the 4095 surgical table.The technician tested the table by applying weight to the table and found that the table slowly drifted right which is indicative of the tilt cylinder requiring replacement.The technician replaced the tilt cylinder, tested the table, confirmed it to be operating according to specifications, and returned it to service.No additional issues have been reported.
 
Event Description
The user facility reported that during a patient procedure their 4095 surgical table drifted downward and to the right without being commanded to do so resulting in a procedure delay.The procedure was completed successfully.No report of injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
4095 GENERAL 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
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key13738977
MDR Text Key287679393
Report Number1043572-2022-00018
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 03/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2022
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 Received02/10/2022
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
-
-