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

Model Number 100145CO2EXT

Device Problem Leak/Splash (1354)

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

Event Date 09/30/2022

Event Type  malfunction  

Event Description

The user facility reported that the pinch clamp for their endo smartcap tubing is not staying closed allowing water to leak onto the floor.No report of injury.

Manufacturer Narrative

The investigation into the reported event is in process; a follow-up report will be submitted when additional information becomes available.

Manufacturer Narrative

Investigation 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 point to detach from the teeth resulting in the reported issue.The issue appears to be isolated to a very small number of clips.We have notified our supplier, and will continue to monitor post-market data for trends.

• Brand Name: ENDO SMARTCAP TUBING
• Type of Device: 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: 15685458
• MDR Text Key: 307104627
• Report Number: 1651395-2022-00026
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 00677964059087
• UDI-Public: 00677964059087
• 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,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100145CO2EXT
• Device Lot Number: 550909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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