MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE SYNERGY WASHER

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The user facility reported a scrub technician was standing next to the washer during the time of the reported event; the employee's eardrum ruptured due to the noise of the burst pipe.Another employee present stated they did not feel well and sought medical treatment.The steris service technician present reported he was fine.The steris service technician inspected the washer and found the hose connecting the facility shutoff valve to the washer's steam pipe had burst.The steam pipe subject of the reported event was not properly installed by the user facility prior to the steris service technician's start up of the washer.The user facility re-piped the washer and steris was able to successfully start-up the washer, run a test cycle and place the washer into service.No additional issues have been reported.The washer was manufactured in 2009 and is serviced and maintained by the user facility.

Event Description

The user facility had completed the re-install of their reliance synergy washer and contacted steris to start up the unit.The steris service technician was running the first test cycle and during this cycle the steam pipe burst.

• Brand Name: RELIANCE SYNERGY WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5156127
• MDR Text Key: 28848585
• Report Number: 9680353-2015-00069
• 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
• Type of Report: Initial
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/17/2015
• 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 Number: 1