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U.S. Department of Health and Human Services

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

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STERIS CANADA CORPORATION AMSCO 3052 WASHER/DISINFECTOR Back to Search Results
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).
 
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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 Key10877498
MDR Text Key228350757
Report Number9680353-2020-00036
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received11/20/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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