MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. ATLAS TRANSFER CARRIAGE

Device Problem Collapse (1099)

Patient Problem No Code Available (3191)

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

The instruments subject of the reported event were reprocessed prior to use.A steris service technician arrived onsite to inspect the atlas transfer carriage following the reported event.The technician was informed that as the employee was removing a load from the sterilizer, the wheel on the transfer carriage came off, causing the transfer carriage to tilt and fall to the floor.The technician inspected the unit and was able to duplicate the reported event.Upon further inspection, the technician found that the bolt used to keep the transfer carriage wheel in place was loose allowing it to fall out.The technician replaced the wheel and tightened the bolt, tested the transfer carriage and found the unit to be operating according to specification.No additional issues have been reported.

Event Description

The user facility reported their atlas transfer carriage collapsed as an employee was removing a load from the sterilizer.Medical treatment was sought.The facility would not disclose if medical treatment was administered.

• Brand Name: ATLAS TRANSFER CARRIAGE
• Type of Device: TRANSFER CARRIAGE
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8635769
• MDR Text Key: 146248813
• Report Number: 3005899764-2019-00054
• 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: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/23/2019
• 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