ENDO SMARTCAP 100165CO2EXTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00677964059124), received between Dec 13, 2023 and Dec 13, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR CLAMP TO THEIR ENDO SMARTCAP TUBING DID NOT CLOSE FULLY AND OPENED ON ITS OWN. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320870 ↗
• MalfunctionDec 13, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR CLAMP TO THEIR ENDO SMARTCAP TUBING DID NOT CLOSE FULLY AND OPENED ON ITS OWN. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320867 ↗

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-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-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-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-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-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-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-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