MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 49" TRANSFER CARRIAGE; TRANSFER CARRIAGE TO STERILIZER

Device Problem Component Falling (1105)

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

Event Date 04/11/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician inspected the transfer carriage and found that the locking mechanism was slightly low.If the locking mechanism is not at the proper height for locking to the sterilizer while loading and unloading it may cause the reported event to occur.The technician adjusted the locking mechanism, tested the transfer carriage and confirmed it to be operating properly.No additional issues have been reported.

Event Description

The user facility reported that an employee was in the process of unloading the sterilizer and the front of the transfer carriage fell to the ground.No report of injury.

• Brand Name: 49" TRANSFER CARRIAGE
• Type of Device: TRANSFER 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5633879
• MDR Text Key: 44904474
• Report Number: 3005899764-2016-00034
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• 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: 04/11/2016
• 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