MAUDE Adverse Event Report: STERIS CANADA ULC VISION 1327 CART AND UTENSIL WASHER/DISINFECTOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/05/2021

Event Type  malfunction  

Manufacturer Narrative

While performing service activities, the technician noticed that water began to leak from the unit.The technician attempted to move away from the unit and in the process, he tripped resulting in the reported event.The technician performed an inspection and found that one of the hose on the unit split resulting in the reported leak.The technician made the necessary repairs, tested the unit, confirmed it was operating according to specification, and returned it to service.No additional issues have been reported.

Event Description

A steris service technician obtained an injury to his right hand and knee while performing a service activity on the user facility's vision 1327 cart and utensil washer/disinfector.Medical treatment was sought and administered.The technician returned to work the same day.

• Brand Name: VISION 1327 CART AND UTENSIL 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 road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 11939085
• MDR Text Key: 265151396
• Report Number: 9680353-2021-00028
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 06/04/2021
• 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