MAUDE Adverse Event Report: MEDIVATORS INC. ENDO SMARTCAP; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number 100145CO2EXT

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 05/26/2023

Event Type  malfunction  

Event Description

Tubing not "spitting water when button was depressed." tubing changed and scope functioning correctly.Manufacturer response for endoscopy tubing, endosmartcap tubing (per site reporter).Equipment failure reported to customer service.Equipment available for return to manufacturer.

• Brand Name: ENDO SMARTCAP
• Type of Device: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): MEDIVATORS INC.; 3150 pollok drive; conroe TX 77303
• MDR Report Key: 17189891
• MDR Text Key: 317746416
• Report Number: 17189891
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 579143
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1