MAUDE Adverse Event Report: STERIS CANADA CORPORATION RECT1CON50 TUBING SET

Device Problem Entrapment of Device (1212)

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

Event Date 03/05/2020

Event Type  malfunction  

Manufacturer Narrative

The rect1con50 tubing set connects the ultrasound bronchoscope to a reliance endoscope storage cabinet.One of the connections attaches via the leur lock to the irrigation port of the ultrasound bronchoscope.A steris account manager confirmed that the plastic connector for the leur lock had detached.Per discussion with user facility personnel, the connector was found lodged in the port after the procedure and prior to reprocessing.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 that the leur lock connector to their rect1con50 tubing set was found lodged in the irrigation port of an ultrasound bronchoscope following a patient procedure.No report of injury.

Manufacturer Narrative

The customer was provided with a replacement tubing set.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.

• Brand Name: RECT1CON50 TUBING SET
• 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: 9917206
• MDR Text Key: 203520310
• Report Number: 9680353-2020-00018
• 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: 04/02/2020
• 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: 03/09/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 03/09/2020; 03/09/2020
• Supplement Dates FDA Received: 04/29/2020; 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