MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. TRANSFER CART; TRANSFER CART TO STERILIZER

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2016

Event Type  No Answer Provided  

Manufacturer Narrative

No procedural delays or cancellation were reported.A steris service technician arrived on site, inspected the unit, and identified facility personnel were not properly locking the transfer cart to the sterilizer.As the transfer cart was not locked properly to the sterilizer it allowed the transfer cart to fall to the ground while the employee was unloading the sterilizer.The investigation is currently in process, a follow up mdr will be filed when additional information becomes available.

Event Description

The user facility reported their 66" transfer cart was not operating properly.No injury was reported.

Manufacturer Narrative

The technician confirmed the sterilizer was operating according to specification.Steris personnel reviewed the transfer cart's dhr and confirmed the unit was manufactured according to specification.The unit is not under steris contract for maintenance services.In service training for the proper use and operation of the transfer cart was completed at the user facility.No additional issues have been noted.

• Brand Name: TRANSFER CART
• Type of Device: TRANSFER CART 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5581556
• MDR Text Key: 43630628
• Report Number: 3005899764-2016-00031
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• 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: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• 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
• Date Manufacturer Received: 03/16/2016
• 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
• Patient Sequence Number: 1