ENDO SMARTCAP 100145CO2EXTRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00677964059087), received between Aug 30, 2017 and Nov 6, 2025 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (15 reports).

7 other recalls cover devices cleared under the same FDA submission (K093665); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• 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 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 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 ↗
• MalfunctionDec 14, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR ENDO SMARTCAP TUBING PINCH CLAMP WILL NOT STAY CLAMPED AND CAUSES WATER TO LEAK OUT. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18329756 ↗
• MalfunctionDec 13, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE CLAMP TO THEIR ENDO SMARTCAP TUBING WOULD NOT STAY CLAMPED AND LEAKED POST PROCEDURE. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18323621 ↗
• MalfunctionDec 13, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR CLAMP TO THEIR ENDO SMARTCAP TUBING WOULD NOT STAY CLAMPED AND LEAKED POST PROCEDURE. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320871 ↗
• MalfunctionJul 20, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE USER FACILITY REPORTED VIA MEDWATCH REPORT (B)(4) THAT THE TUBING WAS NOT "SPITTING WATER WHEN BUTTON WAS DEPRESSED." THE TUBING WAS CHANGED AND THE SCOPE FUNCTIONED CORRECTLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17362691 ↗
• MalfunctionFeb 2, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE USER FACILITY REPORTED VIA 1501150000-2022-8070 THAT THEIR ENDO SMARTCAP TUBING WOULD NOT PRE-TEST APPROPRIATELY. THE TUBING WAS EXCHANGED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO REPORT OF INJURY OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283762 ↗
• MalfunctionFeb 2, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE USER FACILITY REPORTED VIA MEDWATCH 1501150000-2022-8069 THAT THEIR ENDO SMARTCAP TUBING WOULD NOT PRE-TEST APPROPRIATELY. THE TUBING WAS EXCHANGED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO REPORT OF INJURY OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283700 ↗
• MalfunctionNov 4, 2022Leak/Splash; Leak/Splash

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15727770 ↗
• MalfunctionOct 27, 2022Leak/Splash; Leak/Splash

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15685458 ↗
• MalfunctionOct 21, 2022Leak/Splash; Leak/Splash

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15652289 ↗
• MalfunctionOct 21, 2022Leak/Splash; Leak/Splash

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15651551 ↗
• MalfunctionOct 13, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE USER FACILITY REPORTED VIA MEDWATCH (B)(4) THAT THEIR ENDO SMARTCAP TUBING WOULD NOT PRE-TEST APPROPRIATELY. THE TUBING WAS EXCHANGED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO REPORT OF INJURY OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597296 ↗
• InjuryAug 30, 2017Crack; Crack

  A FACILITY REPORTED THAT THE ENDO SMART CAP POPPED OFF OF THE REUSABLE WATER BOTTLE AND MADE A LOUD NOISE. IT WAS REPORTED THAT THE DOCTOR AT THE FACILITY HAD A HEARING TEST DONE AS A RESULT OF THE LOUD NOISE, THUS POTENTIAL INJURY IS BEING REPORTED.

  Patient problems: Hearing Loss

  MAUDE report 6832231 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093665. One submission often covers many models, so check the product and lot details in each record.

• Z-1772-2020 · Oct 9, 2019 · Terminated
  Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50, and found in BMP-C145. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endosco
• Z-1778-2020 · Oct 9, 2019 · Terminated
  Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to sup
• Z-1777-2020 · Oct 9, 2019 · Terminated
  Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigati
• Z-1775-2020 · Oct 9, 2019 · Terminated
  Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10, 50, and found in BMP-C145CO2EXT. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 S
• Z-1774-2020 · Oct 9, 2019 · Terminated
  Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10, 50. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes With Extend
• Z-1776-2020 · Oct 9, 2019 · Terminated
  Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endostat II Irrigation Pump Units. C
• Z-1773-2020 · Oct 9, 2019 · Terminated
  Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50 and found in BMP-C145CO2. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series E