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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 4085 SURGICAL TABLE

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STERIS CORPORATION - MONTGOMERY 4085 SURGICAL TABLE Back to Search Results
Device Problem Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/14/2021
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the table and found surgical tape attached to the locking mechanism of the table's leg section.This prevented the leg section from properly locking with the table resulting in the reported event.The technician cleaned the locking mechanism, tested the leg section and surgical table, confirmed they were operating according to specification, and returned the table to service.The technician counseled user facility personnel on the proper operation of the table specifically to fully remove surgical tape from the table following procedures.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
 
Event Description
The user facility reported the leg section to their 4085 surgical table unlocked with a patient on the table.The patient was transferred to another table resulting in a procedure delay.The procedure was completed successfully.No report of injury.
 
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Brand Name
4085 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 Key11978912
MDR Text Key260466787
Report Number1043572-2021-00042
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 06/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/14/2021
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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