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

Model Number	100145CO2EXT
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that water was leaking from their endo smartcap tubing.The tubing was quickly replaced, and the scope functioned correctly.No report of injury or procedure delay.
Additional Manufacturer Narrative
The endo smartcap tubing set was returned to steris for evaluation.The evaluation confirmed that the body cap component had detached from the body, which likely contributed to the reported event; however, a definitive root cause of the separation could not be determined.A complaint review was conducted and confirmed this to be an isolated event for the subject lot.Steris will continue to monitor for similar events.No additional issues have been reported.

• Brand Name: ENDO SMARTCAP
• 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: 20434761
• Report Number: 1651395-2024-00021
• Device Sequence Number: 7859948
• Product Code: FAJ
• UDI-Device Identifier: 00677964059087
• UDI-Public: (01)00677964059087(17)270715(10)633334
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K093665
• 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): 10/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 100145CO2EXT
• Device Lot Number: (10)633334
• 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: 09/11/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• 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