MAUDE Adverse Event Report: STERIS CANADA CORPORATION AMSCO 5052 WASHER

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

The facility could not provide a specific date of event or incident that attributed to the reported postponed procedures.We are dispatching a service technician to work with the customer on the issues they are experiencing so as to assist with the operation of the unit.Our evaluation to-date has not identified an issue.The washer was installed in march 2016 and is under steris service agreement for maintenance activities.The last regularly scheduled preventive maintenance was performed on february 5, 2020; no repairs were made at that time, and the unit was confirmed to be operating according to specifications.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported their amsco 5052 washer was not operating properly resulting in postponed procedures.

Manufacturer Narrative

The user facility elected to replace the washer.The replacement washer was installed, tested, and confirmed to be operating according to specifications.The washer is not being returned to steris for evaluation.The last preventive maintenance was performed on february 5, 2020; no repairs were made at the time and the unit was confirmed to be operating according to specification.No additional issues have been reported.

• Brand Name: AMSCO 5052 WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• MDR Report Key: 9830934
• MDR Text Key: 196002363
• Report Number: 9680353-2020-00011
• Device Sequence Number: 1
• Product Code: MEC
• 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: 03/13/2020

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
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1