MAUDE Adverse Event Report: STERIS CANADA ULC 6000 SERIES RELIANCE ENDOSCOPE DRYING AND STORAGE CABINET; ENDOSCOPE DRYING CABINET

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 01/12/2024

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the drying cabinet and found that the back edges of the doorframe on the side of the hinge were sharp resulting in the reported event.While onsite the technician filed down the edges, tested the unit, confirmed it to be operational, and returned it to service.No additional issues have been reported.

Event Description

The user facility reported that an employee obtained a cut on their hand while cleaning their 6000 series reliance endoscope drying and storage cabinet.No medical treatment was sought or administered.

• Brand Name: 6000 SERIES RELIANCE ENDOSCOPE DRYING AND STORAGE CABINET
• Type of Device: ENDOSCOPE DRYING CABINET
• 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 Key: 18669487
• MDR Text Key: 335251045
• Report Number: 9680353-2024-00007
• Device Sequence Number: 1
• Product Code: JRJ
• 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,Followup
• Report Date: 02/08/2024
• 2 Devices were Involved in the Event: 1 2

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: 01/12/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 04/11/2024
• 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