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

Model Number 100160

Device Problem Leak/Splash (1354)

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

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

An in-depth investigation was conducted and determined that the cause of the tubing not staying clamped was attributed to the tip (point) of the clip.The tip is seated within the "teeth" of the clip to keep the clip engaged/closed.As the tip was not sharp/pointy enough, this allowed the tip to detach from the teeth resulting in the reported issue.The supplier was made aware of the complaints associated with this issue.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.

Event Description

The user facility reported that their endo smartcap tubing set clamps are not staying closed.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: 18332221
• MDR Text Key: 330960385
• Report Number: 1651395-2023-00052
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 00677964059551
• UDI-Public: 00677964059551
• 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: 100160
• Device Catalogue Number: 100160
• Device Lot Number: 560738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• 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