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

Model Number	100145CO2EXT
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via 1501150000-2022-8070 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.
Additional 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 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.

• Brand Name: ENDO SMARTCAP TUBING
• Common Device Name: 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: 16283762
• Report Number: 1651395-2023-00006
• Device Sequence Number: 15149940
• Product Code: FAJ
• UDI-Device Identifier: 00677964059087
• UDI-Public: 00677964059087
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 100145CO2EXT
• Device Lot Number: 558597
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown