MAUDE Adverse Event Report: STERIS CANADA CORPORATION RECT1CON2P TUBING SET; DRYING CABINET CONNECTORS

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

The tubing set connects the pentax gi endoscopes to a reliance 6000 series endoscope storage cabinet.A steris service technician arrived onsite to inspect the reliance 6000 series endoscope storage cabinet and found it to be operating properly; no repairs were required.The customer was provided with a replacement tubing set.A 3-year complaint review indicates this to be an isolated event.The investigation of this event is currently in process; a follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported via (b)(6) report that they observed black spots on their tubing set.No report of injury.

Manufacturer Narrative

Steris evaluated a tubing set provided by the user facility and could not confirm the reported back spots.Steris has requested additional tubing set samples from the user facility; to date, the user facility has not provided additional samples.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: RECT1CON2P 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: 10718277
• MDR Text Key: 214154175
• Report Number: 9680353-2020-00032
• Device Sequence Number: 1
• Product Code: JRJ
• 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: 10/22/2020
• 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: 09/23/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 09/23/2020; 09/23/2020
• Supplement Dates FDA Received: 12/28/2020; 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