ENDO SMARTCAPRecalls & reported problems across all models
Medivators Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 5 models of ENDO SMARTCAP by Medivators Inc. in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Aug 30, 2017 and Feb 20, 2026 — classified as 1 injury, 29 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (24 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ENDO SMARTCAP problems
Device problems
- Leak/Splash24
- Device Difficult to Setup or Prepare3
- Crack1
- No Apparent Adverse Event1
- No Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- Hearing Loss1
ENDO SMARTCAP models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ENDO SMARTCAP 100145CO2EXTCystoscope And Accessories, Flexible/Rigid21 reports
- Endo SmartCap 100164CO2EXTCystoscope And Accessories, Flexible/Rigid4 reports
- ENDO SMARTCAP 100165CO2EXTCystoscope And Accessories, Flexible/Rigid2 reports
- ENDO SMARTCAP 100160Cystoscope And Accessories, Flexible/Rigid2 reports
- ENDO SMARTCAP 100150CO2Cystoscope And Accessories, Flexible/Rigid1 report
Recent ENDO SMARTCAP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2026Leak/Splash
THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THE SCOPE AIR/WATER VALVE DURING USE OF MULTIPLE OF THEIR ENDO SMARTCAP TUBING DEVICES. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401777 ↗MalfunctionJan 28, 2026Leak/Splash
THE USER FACILITY REPORTED THAT WATER WAS SPRAYING FROM THE AIR/WATER VALVE DURING A PROCEDURE WHICH INCLUDED USE OF THE ENDO SMARTCAP TUBING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24203869 ↗MalfunctionJan 21, 2026Leak/Splash
THE USER FACILITY REPORTED THAT WATER WAS SPRAYING FROM THE AIR/WATER VALVE DURING A PROCEDURE WHICH INCLUDED USE OF THE ENDO SMARTCAP TUBING. USER FACILITY PERSONNEL REPLACED THE TUBING AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24135695 ↗MalfunctionNov 6, 2025No Flow; No Flow
THE USER FACILITY REPORTED VIA MEDWATCH MW5175732 THAT, "AFTER HOOKING UP THE ENDO TUBING TO THE SCOPE, NO AIR OR WATER WOULD COME THROUGH THE SCOPE. MALFUNCTION NOTED PRIOR TO USE ON PATIENT. NO PATIENT HARM." NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23489938 ↗MalfunctionMay 1, 2025Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED A LEAK FROM THEIR ENDO SMARTCAP TUBING. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21944720 ↗MalfunctionOct 11, 2024Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR ENDO SMARTCAP TUBING. THE TUBING WAS QUICKLY REPLACED, AND THE SCOPE FUNCTIONED CORRECTLY. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20434761 ↗MalfunctionDec 20, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR ENDO SMARTCAP TUBING UNCLAMPED FOLLOWING A SUCCESSFULLY COMPLETED PROCEDURE CAUSING WATER TO LEAK OUT. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18363303 ↗MalfunctionDec 14, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THE PINCH CLIP TO THEIR ENDO SMARTCAP TUBING UNCLAMPED CAUSING WATER TO LEAK OUT. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18333019 ↗MalfunctionDec 14, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR ENDO SMARTCAP TUBING LEAKED AND FLOODED THE FLOOR ON SEVERAL OCCASIONS. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18332620 ↗MalfunctionDec 14, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THE PINCH CLIP TO THEIR ENDO SMARTCAP TUBING WAS NOT OPERATING PROPERLY. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18332506 ↗MalfunctionDec 14, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR ENDO SMARTCAP TUBING WAS COMING UNCLAMPED EVEN IF THE CLAMP WAS ON THE TIGHTEST SETTING. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18332223 ↗MalfunctionDec 14, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR ENDO SMARTCAP TUBING CLAMP WILL NOT STAY SHUT. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18332222 ↗MalfunctionDec 14, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THEIR ENDO SMARTCAP TUBING SET CLAMPS ARE NOT STAYING CLOSED. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18332221 ↗MalfunctionDec 14, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT WHILE SETTING UP THEIR ENDO SMARTCAP TUBING, AN ENDO TECHNICIAN NOTICED THE CLAMP WAS EXTREMELY HARD TO CLOSE AND THE CO2 WOULD NOT PASS THROUGH THE TUBING. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18332216 ↗MalfunctionDec 14, 2023Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT THE PINCH CLAMP TO THEIR ENDO SMARTCAP TUBING WOULD NOT STAY CLOSED. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18332215 ↗
Other Medivators Inc. products
All Medivators Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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