RIGID SHEATH FOR LTF-190-10-3D MAJ-2079Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04953170340741), received between Dec 21, 2021 and Jul 11, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (5 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2024Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THE DEFLECTABLE VIDEOSCOPE HAD IMAGE PROBLEM. SYNC ERROR ON POWER BOX AND DOES NOT DISPLAY 3D CAMERA. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725440 ↗
• MalfunctionMar 22, 2024Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE FLEX DEFLECTABLE VIDEOSCOPE EXHIBITED A DETERIORATION OF THE ADHESIVES OF THE DISTAL END VERY LIKELY DUE TO CHEMICAL STRESS AND AN EXPOSITION TO HEAT DURING THE CLEANING OR DISINFECTION PROCESS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18964619 ↗
• MalfunctionFeb 2, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DEFLECTABLE VIDEOSCOPE EXHIBITED PEELING OF THE OBJECTIVE LENS ADHESIVE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18630259 ↗
• MalfunctionAug 10, 2023No Display/Image; No Display/Image

  IT WAS REPORTED TO OLYMPUS THAT DURING A REPROCESSING OF THE DEVICE (AFTER A PROCEDURE), A VIDEOSCOPE HAD AN IMAGE PROBLEM. THE PATIENT WAS NOT UNDER ANESTHESIA. CUSTOMER REPORTED THE DEVICE HAD IMAGE ISSUE, SHOWING NO IMAGE OCCASIONALLY. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE ISSUE FOUND DURING INTAKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17503458 ↗
• MalfunctionJul 18, 2023Defective Component; Defective Component

  THE ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE WAS RETURNED AS PART OF THE ASSET RETURN PROCESS. DURING ROUTINE INSPECTION OF THE DEVICE BY OLYMPUS, DEFECTS OF THE UNIVERSAL CORD/DISTAL END/ CONNECTOR/CONTROL SECTION/RELATED PARTS WERE NOTICED. THERE WAS NO PROCEDURAL OR PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343838 ↗
• MalfunctionJun 16, 2023Poor Quality Image; Poor Quality Image

  THE OLYMPUS EMPLOYEE REPORTED THAT THE ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE WAS FOUND TO HAVE PINHOLE ON THE BENDING SECTION RUBBER. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND FOGGY IMAGE WAS PRODUCED ON THE ENDOSCOPE. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148452 ↗
• MalfunctionJun 5, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THERE WAS AN AIR/WATER LEAKAGE FROM THE DISTAL END OF THE ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS RETURNED AND EVALUATED, AND ADHESIVE AROUND OBJECTIVE LENS IS PEELED. THIS MDR (MEDICAL DEVICE REPORT) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059086 ↗
• MalfunctionMay 18, 2023No Display/Image; No Display/Image

  THE OLYMPUS REPRESENTATIVE REPORTED (ON BEHALF OF THE CUSTOMER), THAT DURING PREPARATION FOR USE. THE ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE, WHILE BEING USED WITH THE EVIS EXERA III VIDEO SYSTEM CENTER. DID NOT DISPLAY AN IMAGE OR THE 3D IMAGE FUNCTION. THE INTENDED THERAPEUTIC PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIMILAR DEVICE WITH NO DELAY. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955971 ↗
• MalfunctionApr 4, 2023Component Missing; Component Missing

  THE CUSTOMER RETURNED THE DEVICE TO OLYMPUS FOR AN UNSPECIFIED MALFUNCTION. THERE WAS NO REPORT OF PATIENT HARM. THE DEVICE EVALUATION FOUND THAT THERE WAS DETERIORATION OF THE OBJECTIVE LENSES GLUING WITH MISSING PARTS. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678855 ↗
• MalfunctionNov 29, 2022Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE DEVICE WAS DISPLAYING AN ABNORMAL IMAGE. THE DEVICE WAS SENT TO SERVICE WHERE EVALUATION FOUND A B30 ERROR. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE EVENT FOUND AT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15878551 ↗
• MalfunctionNov 15, 2022Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE DEVICE WAS DISPLAYING AN ABNORMAL IMAGE. THE REPORTED PROBLEM WAS FOUND DURING REPROCESSING. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. WHEN THE DEVICE WAS SENT TO SERVICE, EVALUATION FOUND A B30 ERROR. THIS REPORT IS BEING SUBMITTED FOR THE B30 ERROR FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15801710 ↗
• MalfunctionNov 15, 2022Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE DEVICE WAS HAVING CONNECTION ISSUES. THE REPORTED PROBLEM WAS FOUND DURING A UNKNOWN PROCEDURE, WHICH WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. WHEN THE DEVICE WAS RETURNED TO SERVICE, A B30 ERROR WAS FOUND. THIS REPORT IS BEING SUBMITTED FOR THE B30 ERROR FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15801278 ↗
• MalfunctionNov 15, 2022Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTS THE PROCEDURE WAS A LAPAROSCOPIC SURGERY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15798634 ↗
• MalfunctionNov 15, 2022Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE DEVICE WAS HAD AN IMAGE PROBLEM. THE REPORTED PROBLEM WAS FOUND DURING A LAPAROSCOPIC SURGERY PROCEDURE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. WHEN THE DEVICE WAS RETURNED TO SERVICE, EVALUATION FOUND A B30 ERROR. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE B30 FOUND DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15798405 ↗
• MalfunctionApr 21, 2022Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THERE WAS A PINHOLE AT THE TIP [DISTAL END] OF THE SUBJECT DEVICE. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, SERVICE FOUND THAT THE ADHESIVE PART OF THE OBJECTIVE LENS WAS PEELED OFF. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING THE DEVICE EVALUATION (ADHESIVE PEELED OFF).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166926 ↗
• MalfunctionDec 21, 2021Leak/Splash; Leak/Splash

  A USER FACILITY REPORTED TO OLYMPUS THAT, THE ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE LEAKED. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE UNIVERSAL CORD WAS DEFECTIVE, THE ADHESIVE OF THE DISTAL END CHIPPED, PEELED OFF AND BREAK. THIS REPORT IS BEING SUBMITTED FOR THE EVENT FOUND DURING EVALUATION. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056291 ↗