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

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

All instruments were reprocessed prior to use.A steris service technician arrived onsite following the reported event to inspect the unit and found that the transfer carriage and docking station was damaged.Due to the damage observed, the transfer carriage and docking station were unable to be tested by the technician.Based on the description of the event, the employee did not properly align the transfer carriage with the sterilizer's docking station causing an inadequate latch of the transfer carriage's front wheels resulting in the reported event.The technician counseled user facility personnel on the proper use and operation of the evolution transfer carriage, specifically properly engaging the transfer carriage with the docking station.The technician replaced the docking station and ordered a replacement transfer carriage.No additional issues have been reported.

Event Description

The user facility reported that while an operator was unloading their sterilizer, the evolution transfer carriage fell to the ground.No report of injury.

Manufacturer Narrative

This mdr is being filed as a correction to the initial report.The unit subject of the report is an evolution sterilizer, not an evolution transfer carriage.The initial report was filed in error as no adverse event occurred with the evolution sterilizer.The sterilizer was tested, confirmed to be operating according to specifications, and returned to service.The details of the adverse event with the evolution transfer carriage can be found in mdr # 3005899764-2020-00059.No additional issues have been reported.

• Brand Name: EVOLUTION STERILIZER
• Type of Device: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• MDR Report Key: 10583889
• MDR Text Key: 208976905
• Report Number: 3005899764-2020-00060
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1