MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. TRANSFER CARRIAGE FOR AMSCO 400 STERILIZER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the transfer carriage.No issue with the function or operation of the transfer carriage was identified.No repairs were required; the unit was returned to service.Upon discussion with user facility personnel, the technician determined the transfer carriage was being overloaded, resulting in it to be more difficult to move and the reported event to occur.The technician counseled the user facility personnel on the importance of assuring the carriages are not overloaded.No additional issues have been reported.

Event Description

The user facility reported that an employee experienced an injury to their shoulder over a period of time from loading and unloading loads with their transfer carriage for their amsco 400 sterilizer.The employee sought medical treatment and missed time from work as a result.

• Brand Name: TRANSFER CARRIAGE FOR AMSCO 400 STERILIZER
• 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 ; 3927453
• MDR Report Key: 9885408
• MDR Text Key: 199554583
• Report Number: 3005899764-2020-00018
• 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: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• 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
• Date Manufacturer Received: 02/25/2020
• 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