• 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. 66" EVOLUTION 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. 66" EVOLUTION TRANSFER CARRIAGE TRANSFER CARRIAGE TO STERILIZER Back to Search Results
Device Problems Unstable (1667); Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2018
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the 66" evolution transfer carriage and found that the locking pin was not at the proper height. If the locking pin is not at the proper height while loading and unloading, it may cause the transfer carriage to not properly engage with the docking station subsequently allowing the transfer carriage to fall to the floor. The root cause of the event was attributed to a loose nut and absence of threadlock subsequently allowing the locking pin to move to an improper height. The technician adjusted the locking pin to the proper height, tested the transfer carriage, confirmed it to be operating according to specification, and returned it to service. The unit was installed at the user facility in january 2018 and is currently under steris warranty. The transfer carriage was installed by a third-party service provider. Steris performed in-service training with the third-party service provider on the proper installation of the 66" evolution transfer carriage, specifically adjusting the locking pin. A 2-year complaint review indicates this to be an isolated event and no additional issues have been reported.

 
Event Description

The user facility reported that an employee was pulling their 66" evolution transfer carriage away from the sterilizer when the transfer carriage became unstable and fell to the floor. No report of injury. All instruments were reprocessed prior to use.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name66" EVOLUTION 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
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 Key8165811
MDR Text Key130636603
Report Number3005899764-2018-00109
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 12/14/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/14/2018
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 Received11/14/2018
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

-
-