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

Device Problems Insufficient Information (3190); Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 01/27/2024

Event Type  malfunction  

Event Description

The user facility reported that an employee obtained a laceration to their hand while cleaning their reliance endoscope drying and storage cabinet.The employee elected not to seek or receive medical treatment however, self-treatment was administered.

Manufacturer Narrative

Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Manufacturer Narrative

A steris service technician inspected the reliance endoscope drying and storage cabinet and found sharp edges around the unit's door frame.Service measures were put into place and appropriate repairs were completed.The steris service technician tested the unit, confirmed it to be operating to specifications and returned it to service.No additional issues have been reported.

• Brand Name: RELIANCE ENDOSCOPE DRYING AND STORAGE CABINET
• Type of Device: ENDOSCOPE 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: 18788909
• MDR Text Key: 336420367
• Report Number: 9680353-2024-00009
• Device Sequence Number: 1
• Product Code: JRJ
• 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,Followup,Followup
• Report Date: 02/27/2024
• 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: 01/31/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 01/31/2024; Not provided
• Supplement Dates FDA Received: 03/08/2024; 04/24/2024
• 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