MAUDE Adverse Event Report: STERIS CANADA CORPORATION SCS NON-MOTORIZED CONVEYOR

Device Problems Component Falling (1105); Sticking (1597); Device Dislodged or Dislocated (2923)

Patient Problem Bruise/Contusion (1754)

Event Date 06/23/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A steris field service technician was already onsite performing maintenance on the reliance vision single chamber washer/disinfector when the customer reported the event.The technician inspected the unit and identified the conveyor system's plastic corner guide had broken.The technician replaced the corner guide, tested the system, and confirmed it to be operating according to specification.Section 1 of the operator manual states, "warning - personal injury hazard: risk of crushing or pinching fingers or hands.Keep hands away from any moving part or baskets.Baskets, rollers, feed-in cylinders and feed-out cylinders can start in motion at any time during operation." section 5 states, "damaged plastic side guides can cause basket jams or risks of personal injury.[and to verify] plastic side guides for signs of wear and damage 1 x/month.Replace plastic side guides as required." section 6 of the maintenance manual states, "jam(s) on conveyor line [may be caused by] missing or damaged plastic side or corner guide.Call steris." steris has offered in-service training about proper use and operation of the scs conveyor and the user facility has accepted.

Event Description

The user facility reported a basket became stuck on their scs non-motorized conveyor.An employee intervened and pulled on the basket.The basket dislodged and a tray fell striking the employee on the arm causing a bruise.No medical treatment was sought.The employee applied an ice pack later that day to the injured arm.

• Brand Name: SCS NON-MOTORIZED CONVEYOR
• Type of Device: CONVEYOR
• 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: 4931868
• MDR Text Key: 22648246
• Report Number: 9680353-2015-00046
• 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
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• 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: 06/24/2015
• 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