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

Device Problems Unstable (1667); Device Fell (4014)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 04/12/2021

Event Type  malfunction  

Manufacturer Narrative

All instruments were reprocessed prior to use.The user facility reported that the transfer carriage was damaged due the reported event and not operational.The transfer carriage was removed from service and a replacement transfer carriage was delivered to the user facility.A steris service technician offered to inspect the unit; however, the user facility declined.No additional issues have been reported.

Event Description

The user facility reported an employee was unloading their evolution transfer carriage when the carriage became unstable and fell to the floor resulting in an injury to their shoulder.Medical treatment was sought; the user facility did not disclose if medical treatment was administered.

• Brand Name: EVOLUTION 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: 11821612
• MDR Text Key: 253228278
• Report Number: 3005899764-2021-00022
• 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: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2021
• 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