MAUDE Adverse Event Report: STERIS CANADA CORPORATION AMSCO 3052 WASHER/DISINFECTOR

Device Problem Difficult to Open or Close (2921)

Patient Problem Injury (2348)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

The user facility elected to have their third-party service provider inspect the amsco 3052 washer.The third-party service provider inspected the washer and found it to be operating properly; no repairs were required.The third-party could not duplicate the reported door jam.A steris account manager arrived onsite and was informed by user facility personnel that the door opened approximately 3 inches and then stopped.The employee placed their fingers under the door to attempt to open it when the door closed on the employee's fingers resulting in the reported event.The amsco 3052 washer operator manual states (1-1), "warning - personal injury hazard: risk of pinch point between door and threshold when door opens, keep fingers away from threshold." the account manager performed in-service training on the proper use and operation of the amsco 3052 washer, specifically keeping fingers away from the door threshold.No additional issues have been reported.

Event Description

Hold for r.G.1.20 the user facility reported the door to their amsco 3052 washer did not fully open; an employee attempted to manually open the door resulting in a hand injury.Medical treatment was administered (stitches).

• Brand Name: AMSCO 3052 WASHER/DISINFECTOR
• Type of Device: WASHER/DISINFECTOR
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 10877498
• MDR Text Key: 228350757
• Report Number: 9680353-2020-00036
• Device Sequence Number: 1
• Product Code: MEC
• 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: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/20/2020
• 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