MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 600 STERILIZER

Model Number AMSCO 600 Steam Sterilizer

Device Problem Leak/Splash (1354)

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

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the units and found that the sight glass required replacement.The technician replaced the sight glass, confirmed the units to be operating according to specification, and returned them to service.No additional issues have been reported.

Event Description

The user facility reported that steam was leaking from two of their amsco 600 sterilizers onto the floor.No report of injury.

• Brand Name: AMSCO 600 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
• 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: 12365405
• MDR Text Key: 268060316
• Report Number: 3005899764-2021-00045
• Device Sequence Number: 1
• Product Code: FLE
• UDI-Device Identifier: 00724995179427
• UDI-Public: 00724995179427
• 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,Followup
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AMSCO 600 Steam Sterilizer
• Device Catalogue Number: EF1201242
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2021
• 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