• 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" TRANSFER CARRIAGE TRANSFER CARRIAGE TO THE 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" TRANSFER CARRIAGE TRANSFER CARRIAGE TO THE STERILIZER Back to Search Results
Device Problem Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/07/2018
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived to inspect the transfer carriage following the reported event. The technician was informed that while unloading instruments from the sterilizer, the transfer carriage's front wheels did not lock into the sterilizer docking station; causing the front of the transfer carriage to fall to the floor. The instrument packs present on the loading cart did not contact the floor and did not require reprocessing. The technician identified that the front of the transfer carriage had been damaged upon contacting the floor during the event and was unable to test the functionality of the transfer carriage. Based on the description of the event, it appears that the employee did not fully engage the transfer carriage to the sterilizer's docking station prior to removing the rack from the sterilizer. The transfer carriage was removed from service following the reported event and a replacement transfer carriage was delivered to the user facility. No additional issues have been reported. A steris account manager is scheduled to perform in-service training on the proper procedure while loading and unloading the sterilizer on (b)(6) 2018.

 
Event Description

The user facility reported their 54" transfer carriage fell to the ground while an operator was removing a processed load from the sterilizer. No report of injury or procedure delay.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name54" TRANSFER CARRIAGE
Type of DeviceTRANSFER CARRIAGE TO THE 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
Manufacturer (Section G)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, nuevo leon 67190
MX 67190
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key8139381
MDR Text Key129591595
Report Number3005899764-2018-00105
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,Followup
Report Date 12/06/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/06/2018
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2018
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

-
-