• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. EVOLUTION TRANSFER CARRIAGE

  • 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 MEXICO, S. DE R.L. DE C.V. EVOLUTION TRANSFER CARRIAGE Back to Search Results
Device Problem Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/06/2019
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the evolution transfer carriage. The technician found that the release rod had become unscrewed, allowing the transfer carriage wheels to move and cause the transfer carriage to become unbalanced and fall. The root cause of the reported event can be attributed to the bolt on the release rod. The bolt had become loose over time allowing the reported event to occur. The technician re-tightened the bolt on the release rod, tested the unit, and found the transfer carriage to be operating according to specification. The unit was returned to service. While onsite, the technician inspected all other transfer carriages confirming there were no similar issues with the other units. A two-year complaint review indicates this to be an isolated event. No additional issues have been reported.

 
Event Description

The user facility reported their evolution transfer carriage fell while removing a load from the sterilizer. No report of injury or procedure delay.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEVOLUTION TRANSFER CARRIAGE
Type of DeviceTRANSFER CARRIAGE
Manufacturer (Section D)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, 67190
MX 67190
Manufacturer (Section G)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, 67190
MX 67190
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key8658295
MDR Text Key146932825
Report Number3005899764-2019-00057
Device Sequence Number1
Product Code FLE
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 05/31/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/31/2019
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2019
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

-
-