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

Model Number	100150CO2
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the event was not returned for evaluation.Without return of the device, a root cause could not be determined.The dhr for the lot subject of this event was reviewed and no abnormalities were noted.There have been no other complaints associated with this lot.No additional issues have been reported.
Event or Problem Description
The user facility reported that their endo smartcap tubing leaked and flooded the floor on several occasions.No report of injury or procedure delay.

• Brand Name: ENDO SMARTCAP TUBING
• Common Device Name: INSUFFLATION 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: 18332620
• Report Number: 1651395-2023-00054
• Device Sequence Number: 12863666
• Product Code: FAJ
• UDI-Device Identifier: 00677964059506
• UDI-Public: 00677964059506
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 12/14/2023

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: 100150CO2
• Device Catalogue Number: 100150CO2
• Device Lot Number: 582989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2023
• 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