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

Model Number 6000 SERIES

Device Problem Sharp Edges (4013)

Patient Problem Abrasion (1689)

Event Date 06/16/2023

Event Type  malfunction  

Manufacturer Narrative

The user facility engineering team inspected the endo drying cabinet and found several unsmoothed edges.The unit was removed from service and instruction was given to the user facility personnel to avoid using the cabinet until repairs have been made.A steris service technician arrived onsite following the reported event to inspect the drying and storage cabinet.The technician found several sharp edges within the unit potentially causing the reported event to occur.The shelving within the drying and storage cabinet will be replaced, and all sharp edges will be smoothed out.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

Event Description

The user facility reported that an employee obtained a cut injury while retrieving equipment from their reliance 6000 series endoscope storage cabinet.Medical treatment was sought and administered (stitches).

Manufacturer Narrative

The technician replaced the shelving and all sharp edges on the unit were smoothed out.The unit was tested, confirmed to be operating according to specifications, and returned to service.No additional issues have been reported.

• Brand Name: RELIANCE 6000 SERIES ENDOSCOPE STORAGE CABINET
• Type of Device: DRYING AND STORAGE 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: 17321632
• MDR Text Key: 319011067
• Report Number: 9680353-2023-00025
• Device Sequence Number: 1
• Product Code: JRJ
• UDI-Device Identifier: 00724995168124
• UDI-Public: 00724995168124
• 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,Followup
• Report Date: 07/13/2023
• 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
• Device Model Number: 6000 SERIES
• Device Catalogue Number: REC6202DS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 06/16/2023; 06/16/2023
• Supplement Dates FDA Received: 08/18/2023; 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