MAUDE Adverse Event Report: STERIS CORPORATION - HOPKINS AMSCO-C STERILIZER

Device Problem Arcing (2583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Prior to the reported event the water pressure was out of specification at 85psi.The recommended water pressure range is 20-50psi.During manufacturing, the sterilizer is given a factory voltage identifier tag which is held by a thin wire passing through the ventilation slates of the electrical kick plate.When the plumber turned over the tag the small tag wire made contact with the electrical connections behind the electrical kick plate subsequently causing the wire to become charged and grounded on the base metal fin of the kick panel and causing the reported event.The steris service technician replaced the electrical kick plate and confirmed the sterilizer to be operating properly.No additional issues have been reported.The amsco-c sterilizer was installed by a third party on 10/28/2015.Step 1 on the installation checklist states: remove all construction/installation debris and protective paper from the unit.Although the third party checked complete for step 1 on the installation checklist, they did not remove the voltage identifier tag.

Event Description

The user facility reported that their plumber was onsite making adjustments to the water pressure for their amsco-c sterilizer when the unit arched.No report of injury.

• Brand Name: AMSCO-C STERILIZER
• Type of Device: STERILIZER
• Manufacturer (Section D): STERIS CORPORATION - HOPKINS; 6515 hopkins road; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION - HOPKINS; 6515 hopkins road; mentor OH 44060
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5246864
• MDR Text Key: 32053919
• Report Number: 3000251274-2015-00051
• Device Sequence Number: 1
• Product Code: FLE
• 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: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• 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
• Date Manufacturer Received: 10/30/2015
• 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