MAUDE Adverse Event Report: STERIS CANADA CORPORATION RECT1CON10 TUBING SET; DRYING CABINET CONNECTORS

Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

The drying cabinet tubing set connects the scope to a reliance endoscope storage cabinet.One of the connections attaches via the leur lock to the balloon port of the scope.A steris account manager spoke with user facility personnel and 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 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." no additional issues have been reported.

Event Description

Hold for r.G.1.20 the user facility reported that the leur lock connector to their drying cabinet tubing set was found lodged in the balloon port of two of their scopes following two separate patient procedures.No report of injury.

• Brand Name: RECT1CON10 TUBING SET
• Type of Device: DRYING CABINET CONNECTORS
• 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 44060 ; 4403927453
• MDR Report Key: 10679611
• MDR Text Key: 228350761
• Report Number: 9680353-2020-00031
• 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
• Report Date: 10/14/2020
• 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: 09/16/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• 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