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

Model Number 100150CO2

Device Problem Leak/Splash (1354)

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

Event Date 06/28/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 330676665
• Report Number: 1651395-2023-00054
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 00677964059506
• UDI-Public: 00677964059506
• 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: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2023
• 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