MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 60" TRANSFER CARRIAGE; TRANSFER CARRIAGE TO STERILIZER

Device Problem Unstable (1667)

Patient Problem Injury (2348)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

No report of procedure delay or cancellation.During the time of the reported event, the transfer carriage was positioned behind the employee.The employee heard a noise and as they turned around the transfer carriage began to fall.The employee caught the transfer carriage however, the transfer carriage contacted their arm and shoulder.User facility personnel that were present assisted in stabilizing the transfer carriage so it would not fall to the ground.A steris service technician arrived onsite to inspect the transfer carriage and found the unit to be operating properly.The technician spoke with user facility personnel and they stated one of the transfer carriage wheels had fallen off subsequently causing the transfer carriage to become unstable.The user facility is responsible for all service and maintenance activity to their transfer carriages.The technician ordered additional wheels for the user facility to ensure they had available inventory for future maintenance activities.No additional issues have been reported.

Event Description

The user facility reported that an employee obtained an injury after their 60" transfer carriage became unstable.The employee did not seek medical treatment.

• Brand Name: 60" 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 6905168
• MDR Text Key: 88158571
• Report Number: 3005899764-2017-00049
• 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: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• 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?: No
• Date Manufacturer Received: 08/30/2017
• 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