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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA ULC RELIANCE VISION MULTI-CHAMBER WASHER/DISINFECTOR

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STERIS CANADA ULC RELIANCE VISION MULTI-CHAMBER WASHER/DISINFECTOR Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Pain (1994)
Event Date 08/28/2023
Event Type  malfunction  
Manufacturer Narrative
During the time of the reported event, the employee was manually attempting to free an obstruction by pushing the basket into the washer's chamber.When the basket was pushed into the washer chamber and the obstruction was cleared, the washer door lowered down and contacted the employee's hand/wrist.A steris service technician inspected the reliance vision multi-chamber washer/disinfector and found no issues with the function or operation.The employee subject of the reported event did not follow proper operating procedures for clearing an obstruction.The operator manual states, "if an obstruction is present in a chamber door, do not attempt to remove the object.A door obstruction sensor detects the obstruction.Door automatically stops from closing and remains open at any height.(.) 6.If operator is unable to remove obstruction from chamber door, call a qualified service technician." user facility personnel were counseled on the proper use and operation for the reliance vision multi-chamber washer/disinfector specifically the importance of following proper obstruction procedures.The steris service technician returned the unit to service and no additional issues have been reported.
 
Event Description
The user facility reported than an employee obtained an injury to their hand/wrist while trying to remove an obstruction between the reliance vision multi-chamber washer/disinfector's door and safety bar.Medical treatment was sought and administered.
 
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Brand Name
RELIANCE VISION MULTI-CHAMBER 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 rd
mentor, OH 44060
4403927453
MDR Report Key17835844
MDR Text Key324501260
Report Number9680353-2023-00035
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeAS
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 09/28/2023
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
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/29/2023
Initial Date FDA Received09/28/2023
Was Device Evaluated by Manufacturer? Yes
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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