MAUDE Adverse Event Report: STERIS CANADA CORPORATION RECT1CON20 TUBING SET FOR RELIANCE 6000 SERIES ENDOSCOPE STORAGE CABINET

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/02/2020

Event Type  malfunction  

Manufacturer Narrative

A steris account manager provided the customer with replacement tubing sets.The conditions of the reported event are currently under evaluation; a follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported via user facility medwatch report number mw5092247 that the rect1con20 tubing sets for their reliance 6000 series endoscope storage cabinet were breaking following sterilization.No report of injury.

Manufacturer Narrative

A steris account manager observed the tubing sets and confirmed that the plastic connectors for the tubing set were broken.The reliance endoscope storage cabinet operator manual states (4-21), "warning - personal and/or equipment damage hazard: when connecting or disconnecting the channel purge tubing sets from flexible endoscopes, care must be taken to not only protect the endoscope, but also the tubing sets from being damaged.When disconnecting, please make sure you follow these steps to ensure your tubing sets will last and do the job they are intended to do." the operator manual further states (4-23), "do not pull on the tubing set when disconnecting, this can cause breakage of the tubing connectors." additionally, the operator manual states (5-2), "tubing sets and connectors should be checked regularly for cracks, discoloration and loss of tubing flexibility.If any such flaws are found, they should be replaced immediately." a steris account manager discussed the proper use and operation of the tubing sets with user facility personnel.No additional issues have been reported since the replacement tubing sets were provided.

• Brand Name: RECT1CON20 TUBING SET FOR RELIANCE 6000 SERIES ENDOSCOPE STORAGE CABINET
• Type of Device: TUBING SET
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, oh ; 3927453
• MDR Report Key: 9771597
• MDR Text Key: 184679413
• Report Number: 9680353-2020-00007
• 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: 02/28/2020
• 2 Devices were Involved in the Event: 1 2

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: 01/29/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 01/29/2020; 01/29/2020
• Supplement Dates FDA Received: 04/29/2020; 04/11/2024
• 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