• 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. 54" ATLAS TRANSFER CARRIAGE TRANSFER CARRIAGE TO STERILIZER

  • 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. 54" ATLAS TRANSFER CARRIAGE TRANSFER CARRIAGE TO STERILIZER Back to Search Results
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2018
Event Type  malfunction  
Manufacturer Narrative
An employee was in the process of unloading the sterilizer when the transfer carriage became unstable and fell to the ground. The locking mechanism for the front wheels did not lock properly to the docking station in front of the evolution sterilizer. All instruments present were reprocessed prior to use in procedures. The technician found the docking bracket, which locks the loading car to the sterilizer when it is loaded or unloaded, was damaged. The technician adjusted the sterilizer's trim panel and replaced the docking station. The technician returned the transfer carriage to service and no additional issues have been reported. The technician counseled user facility personnel on the proper use and operation of the transfer carriage.
 
Event Description
The user facility reported that their 54" atlas transfer carriage legs would not lock properly. No report of injury.
 
Manufacturer Narrative
Upon further investigation, it was revealed that only the sterilizer's docking station was replaced. Due to the damaged of the transfer carriage, the user facility elected to replace it. The transfer carriage subject of the reported event was removed from service. No issues have been noted with the replacement transfer carriage.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name54" ATLAS TRANSFER CARRIAGE
Type of DeviceTRANSFER CARRIAGE TO STERILIZER
Manufacturer (Section D)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, nuevo leon 67190
MX 67190
MDR Report Key7272019
MDR Text Key100284427
Report Number3005899764-2018-00010
Device Sequence Number1
Product Code FLE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 02/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/15/2018
Is This a Reprocessed and Reused Single-Use Device? No

-
-