MAUDE Adverse Event Report: STERIS CANADA ULC AMSCO 5052 WASHER/DISINFECTOR

Model Number 5052

Device Problems Mechanical Jam (2983); Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/04/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation of the subject event is in process.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that an employee obtained an injury to their hand while operating their amsco 5052 washer.Medical treatment was sought and administered.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the amsco 5052 washer/disinfector and found it to be operating properly.No repairs were required, and the unit was returned to service.The root cause of the reported event is attributed to user error as the employee should not have stuck their hand in the washer as the door was closing.The amsco 5052 washer/ disinfector operator manual states (1-1), "warning - personal injury hazard: risk of pinch point between door and threshold when the door opens.Keep fingers away from threshold." a steris account manager offered in-service training on the proper use and operation of the amsco 5052 washer/disinfector, specifically, assuring hands and fingers are away from the threshold; however, the user facility declined.No additional issues have been reported.

• Brand Name: AMSCO 5052 WASHER/DISINFECTOR
• Type of Device: WASHER/DISINFECTOR
• Manufacturer (Section D): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 14518830
• MDR Text Key: 300354813
• Report Number: 9680353-2022-00018
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 00724995192969
• UDI-Public: 00724995192969
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5052
• Device Catalogue Number: FH14043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2018
• 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