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	07/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed and confirmed the device lot was manufactured to specification.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 device subject of the reported event was returned to medivators for evaluation.Upon initial inspection, it was observed that there was blockage in stopcock stem due to an excess amount of glue.The tubing was then pressurized using a hand pump and it was confirmed that the flow was blocked.The exact cause of the glue issue could not be determined.There have been no other complaints associated with this lot.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch (b)(4) 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
• 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: 15597296
• Report Number: 1651395-2022-00021
• Device Sequence Number: 2278386
• 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): 10/13/2022

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: 550001
• 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: 09/16/2022
• Initial Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown