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

Model Number	100164CO2EXT
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record of the lot subject of the reported event was reviewed and no issues were noted.The investigation into the reported event is in process; a follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that the pinch clamp for their endo smartcap tubing is not staying closed allowing water to leak from scopes and subsequently causing procedure delays.No report of injury.
Additional 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
• 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: 15727770
• Report Number: 1651395-2022-00028
• Device Sequence Number: 2919508
• Product Code: FAJ
• UDI-Device Identifier: 00677964059087
• UDI-Public: 00677964059087
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022

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: 100164CO2EXT
• Device Lot Number: 555370
• 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: 10/07/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• 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