ENDO SMARTCAP 100160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00677964059551), received between Dec 14, 2023 and Dec 14, 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 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 THE PINCH CLIP TO THEIR ENDO SMARTCAP TUBING KEPT UNCLAMPING DURING A PROCEDURE. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18332061 ↗

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-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-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-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-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-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