MAUDE Adverse Event Report: MEDIVATORS, INC. ENDO SMARTCAP TUBING

Model Number 100145CO2EXT

Device Problem Device Difficult to Setup or Prepare (1487)

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

Event Date 12/14/2022

Event Type  malfunction  

Manufacturer Narrative

The endo smartcap tubing instructions for use include the instructions for testing the tubing prior to use.The ifu states, "prime the channel and test for air and water prior to insertion of gi endoscope." the customer properly followed these instructions and replaced the tubing set prior to use.The product number (4005644) provided in the medwatch report is related to an endogator tubing set and not the endo smartcap tubing as described in the reported event.Steris requested the endo smartcap tubing subject of the reported event back for evaluation.Upon return of the device, the correct product number was confirmed (558597) for the endo smartcap tubing.The endo smartcap tubing subject of the reported event was evaluated and found that the stopcock stem was plugged due to excess glue.The tubing was then functionally tested and the tubing did not provide insufflation.

Event Description

The user facility reported via medwatch 1501150000-2022-8069 that their endo smartcap tubing would not pre-test appropriately.The tubing was exchanged and the procedure was successfully completed.No report of injury or patient harm.

• Brand Name: ENDO SMARTCAP TUBING
• Type of Device: TUBING
• Manufacturer (Section D): MEDIVATORS, INC.; 3150 pollok drive; conroe TX 77303
• Manufacturer (Section G): MEDIVATORS, INC.; 3150 pollok dr; conroe TX 77303
• Manufacturer Contact: daniel davy ; 3150 pollok dr; conroe, TX 77303 ; 4403927453
• MDR Report Key: 16283700
• MDR Text Key: 308676761
• Report Number: 1651395-2023-00005
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 00677964059087
• UDI-Public: 00677964059087
• 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
• Report Date: 02/02/2023

1 Device was Involved in the Event

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
• Device Model Number: 100145CO2EXT
• Device Lot Number: 558597
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1