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

Model Number 100165CO2U

Device Problem Connection Problem (2900)

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

Event Date 12/19/2023

Event Type  malfunction  

Manufacturer Narrative

Medivators has requested that the customer return samples from the same lot subject of the event for evaluation.A follow-up report will be submitted when additional information becomes available.There have been no other complaints associated with this lot.

Event Description

The user facility reported via vigilance report to ansm that they had difficulty connecting their endo smartcap tubing to their endoscope at the start of a procedure resulting in a procedure delay.No report of injury.

Manufacturer Narrative

Medivators has sent multiple requests to obtain return samples for evaluation.To date, medivators has not received returned samples from the user facility for evaluation.Without return of the device for evaluation, a root cause could not be determined.The device history record for the lot subject of the event was reviewed and no abnormalities were noted.There have been no other complaints associated with this lot.No additional issues have been reported.

• 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: 18435928
• MDR Text Key: 331810981
• Report Number: 1651395-2024-00001
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/03/2024

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
• Device Operator: Health Professional
• Device Model Number: 100165CO2U
• Device Catalogue Number: 100165CO2U
• Device Lot Number: 586398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2023
• 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