Single Use 3-Lumen Sphincterotome V KD-V411M-3030 (UDI 04953170382673)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04953170382673), received between Oct 4, 2021 and May 10, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (13 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SPHINCTEROTOME EXHIBITED THE KNIFE WIRE WAS BROKEN AND THE WIRE COATING WAS TORN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19291609 ↗
• MalfunctionApr 30, 2024Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED THE LAPARO-THORACO VIDEOSCOPE HAD POOR QUALITY IMAGE. THE ISSUE OCCURRED DURING A PROCEDURE. THE CUSTOMER NOTED THERE MAY BE A POSSIBLE INTERNAL ISSUE AND THERE WAS CONDENSATION FORMING ON THE INSIDE OF THE TIP OF THE SCOPE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE SCOPE IMAGE FAILED A FOG TEST. THE REPORT IS BEING SUBMITTED DUE THE DEFECT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211959 ↗
• MalfunctionApr 30, 2024Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED THE LAPARO-THORACO VIDEOSCOPE HAD POOR IMAGE QUALITY. THE ISSUE OCCURRED DURING A PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE IMAGE WAS VERY CLOUDY. THE REPORT IS BEING SUBMITTED DUE TO THE DEFECT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211917 ↗
• MalfunctionApr 25, 2024Poor Quality Image; Peeled/Delaminated; Poor Quality Image; Peeled/Delaminated

  THE CUSTOMER REPORTED THE LAPARO-THORACO VIDEOSCOPE HAD NO ANGULATION WHEN THE CONTROL LEVER WAS TURNED. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE IMAGE WAS FOGGY AND THE LIGHT GUIDE LENS ADHESIVE WAS PEELED OFF. THE REPORT IS BEING SUBMITTED DUE TO THE DEFECTS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183378 ↗
• MalfunctionApr 25, 2024Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED THE IMAGE OF THE LAPARO-THORACO VIDEOSCOPE WAS GRAINY. THE ISSUE OCCURRED WHEN PREPARING THE SCOPE FOR USE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE IMAGE WAS FOGGY. THE REPORT IS BEING SUBMITTED DUE TO THE DEFECT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183260 ↗
• MalfunctionApr 25, 2024Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED THE IMAGE OF THE LAPARO-THORACO VIDEOSCOPE WAS CLOUDY. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE IMAGE WAS VERY CLOUDY DUE TO FLUID IN THE OBJECTIVE LENS. THE REPORT IS BEING SUBMITTED DUE TO THE FAULT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183245 ↗
• MalfunctionApr 10, 2024Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED THE TIP OF THE LAPARO-THORACO VIDEOSCOPE WAS LEAKING. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE IMAGE WAS FOGGY DUE TO A DAMAGED OBJECTIVE LENS AND CHARGED COUPLED DEVICE (CCD) UNIT. THE REPORT IS BEING SUBMITTED DUE TO THE DEFECT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19079008 ↗
• MalfunctionApr 10, 2024Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED THE IMAGE OF THE LAPARO-THORACO VIDEOSCOPE WAS BLURRY AND THERE WAS AN AIR LEAK. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE IMAGE WAS FOGGY DUE TO A DAMAGED OBJECTIVE LENS. THE REPORT IS BEING SUBMITTED DUE TO THE DEFECT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19078928 ↗
• MalfunctionApr 10, 2024Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED THE BENDING SECTION COVER OF THE LAPARO-THORACO VIDEOSCOPE HAD A HOLE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE IMAGE WAS FOGGY DUE TO A DAMAGED OBJECTIVE LENS AND CHARGED COUPLED DEVICE (CCD) UNIT. THE REPORT IS BEING SUBMITTED DUE TO THE DEFECT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19078741 ↗
• MalfunctionApr 9, 2024Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED THE IMAGE OF THE LAPARO-THORACO VIDEOSCOPE WAS BAD. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE IMAGE WAS FOGGY DUE TO A DAMAGED OBJECTIVE LENS. THE REPORT IS BEING SUBMITTED DUE TO THE DEFECT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069873 ↗
• MalfunctionMar 18, 2024Poor Quality Image; Poor Quality Image

  IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE IMAGE OF THE LAPARO-THORACO VIDEOSCOPE WAS FOGGY. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923722 ↗
• MalfunctionMar 18, 2024Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED THE IMAGE OF THE LAPARO-THORACO VIDEOSCOPE WAS BLURRY. THE ISSUE OCCURRED DURING A PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE IMAGE WAS FOGGY. THE REPORT IS BEING SUBMITTED DUE TO THE DEFECT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18919641 ↗
• MalfunctionMar 14, 2024Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED THE IMAGE OF THE LAPARO-THORACO VIDEOSCOPE WAS BLURRY. THE ISSUE WAS FOUND DURING A PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE IMAGE WAS FOGGY DUE TO A DAMAGED CHARGED COUPLED DEVICE (CCD) UNIT. THE REPORT IS BEING SUBMITTED DUE TO DEFECT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18901004 ↗
• MalfunctionMar 6, 2024Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED THE IMAGE OF THE LAPARO-THORACO VIDEOSCOPE WAS FUZZY AND ONE LIGHT WAS OUT. THE ISSUE OCCURRED DURING A PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE IMAGE WAS FOGGY. THE REPORT IS BEING SUBMITTED DUE TO THE DEFECT FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18846509 ↗
• MalfunctionJan 26, 2024Break; Break

  IT WAS REPORTED, THE SINGLE USE 3-LUMEN SPHINCTEROTOME V'S WIRE BROKE. THE ISSUE OCCURRED DURING A NIPPLE INCISION FOR AN ENDOSCOPIC SPHINCTEROTOMY. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18588184 ↗
• MalfunctionOct 5, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY A NURSE THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY USING THE SUBJECT DEVICE (KD-V411M-0330), THE CUTTING WIRE WAS BROKEN OFF ON ACTIVATION. THE USER CHANGED FROM THE SUBJECT DEVICE FROM ANOTHER DEVICE (KD-V411M-0725). KD-V411M-0725 WAS ALSO BROKEN OFF ON ACTIVATION. THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE FIRST DEVICE (KD-V411M-0330).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12580712 ↗
• MalfunctionOct 4, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM USER FACILITY THAT THE KNIFE WIRE BROKE WHEN ENERGIZED DURING A ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12566769 ↗