n.a, 091279-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04048551428030), received between Mar 19, 2025 and Jun 9, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “No Display/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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Image Display Error/Artifact

  ACCORDING TO THE INFORMATION RECEIVED, ITEM DID NOT WORK WHEN PLUGGED INTO THE TC028 ADAPTER. VIDEO WOULD NOT APPEAR ON THE SCREEN FOR LONGER THAN A SECOND. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25447471 ↗
• MalfunctionMay 22, 2026Optical Problem

  IT HAS BEEN REPORTED THE UROLOGIST HAD TO WITHDRAW THE SCOPE WITHOUT ANY IMAGE (BLIND REMOVAL). THEY HAD TO OPEN A DIFFERENT SCOPE (NOT KARL STORZ) TO FINISH THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25259511 ↗
• MalfunctionApr 28, 2026Break; Positioning Problem

  IT HAS BEEN REPORTED THE DEFLECTION BROKE DURING PROCEDURE. DEFLECTION POPPED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021204 ↗
• MalfunctionApr 2, 2026No Display/Image

  IT WAS REPORTED THAT IMAGE DID NOT COME UP ON THE SCREEN, CHANGED THE ADAPTER AND STILL WOULD NOT COME UP ON THE SCREEN, CHANGED OUT THE SCOPE AND WORKED FINE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772104 ↗
• MalfunctionMar 10, 2026Erratic or Intermittent Display

  IT WAS REPORTED THAT LINES FLICKERING ACROSS THE SCREEN, AND EVENTUALLY TOOK OVER THE WHOLE SCREEN, THEN THE IMAGE DROPPED. ALL COMPLAINTS ON THIS ISSUE HAS BEEN WITH CLEARPETRA USING HIGH-PRESSURE IRRIGATION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561357 ↗
• MalfunctionMar 6, 2026Poor Quality Image

  IT WAS REPORTED THAT THE SCOPE HAD A POOR VIDEO OUTPUT, WITH A PINK HUE ACROSS THE IMAGE. THE CASE WAS DELAYED BY 5 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531374 ↗
• MalfunctionFeb 27, 2026Erratic or Intermittent Display

  IT WAS REPORTED THAT THERE WAS INTERMITTENT IMAGING WOULD BLACK OUT AND THERE WERE LINES IN THE IMAGE. SE VISUALIZED THE ISSUE. SE HAD THEM TRY THE EBOX ADAPTER AND IT WAS THE SCOPE. THE SURGEON SWITCHED TO A REUSABLE SCOPE TO FINISH THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474861 ↗
• MalfunctionJan 12, 2026No Display/Image; Optical Problem

  IT WAS REPORTED THAT WHEN SCOPE PLUGGED INTO X LINK THERE WAS NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039342 ↗
• MalfunctionDec 5, 2025Mechanical Jam; Material Split, Cut or Torn; Mechanical Jam; Material Split, Cut or Torn

  ON (B)(6) 2025 ADDITIONAL INFORMATION WAS RECEIVED THAT THE CONFIRMATION WAS RECEIVED THAT THERE WAS NO ABORTION OF THE SURGERY. THE DEVICE WAS CHANGED, AND THE SURGERY WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729549 ↗
• MalfunctionNov 7, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT HAS BEEN REPORTED: AS SOON AS THEY PLUGGED THE SCOPE INTO CAMERA BOX, IT HAD A SOLID WHITE SCREEN, NO IMAGE, COULD NOT TELL WHERE THEY WERE AT. SWAPPED ADAPTOR. TRIED RESETTING CAMERA BOX NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497147 ↗
• MalfunctionOct 23, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THERE WAS A NO VIDEO IMAGE. NO PATIENT INVOLVEMENT REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A LESS THAN 5 MIN DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367448 ↗
• MalfunctionAug 29, 2025No Display/Image; Optical Problem; No Display/Image; Optical Problem

  IT HAS BEEN REPORTED: THE ISSUE BECAME APPARENT DURING THE PROCEDURE WHEN THE IMAGE WAS EXPERIENCING SOME FORM OF INTERFERENCE OR DISCONNECTION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22928166 ↗
• MalfunctionAug 29, 2025Optical Problem; Optical Problem

  THE FOLLOWING WAS REPORTED: FAULTY IMAGE AND WORKING CHANNEL ISSUES DURING PROCEDURE. THREE SCOPES WERE OPENED AND DIDN'T WORK. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 2027009-2025-02513 AND 2027009-2025-02514.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22927689 ↗
• MalfunctionAug 29, 2025Optical Problem; Optical Problem

  THE FOLLOWING WAS REPORTED: FAULTY IMAGE AND WORKING CHANNEL ISSUES DURING PROCEDURE. THREE SCOPES WERE OPENED AND DIDN'T WORK. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22927688 ↗
• MalfunctionAug 29, 2025Optical Problem; Optical Problem

  THE FOLLOWING WAS REPORTED: FAULTY IMAGE AND WORKING CHANNEL ISSUES DURING PROCEDURE. THREE SCOPES WERE OPENED AND DIDN'T WORK. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 2027009-2025-02513 2027009-2025-02515.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22927687 ↗
• MalfunctionAug 5, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT AFTER PLUGGED IN THE SCOPE WILL TURN ON BUT IMAGE DID NOT SHOW ON THE SCREEN. THIS HAPPENED DURING A CYSTO/URETHRAL DILATION/LEFT URS/LASER. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22722334 ↗
• MalfunctionAug 5, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT AFTER PLUGGED IN THE SCOPE WILL TURN ON BUT IMAGE DID NOT SHOW ON THE SCREEN. THIS HAPPENED DURING A CYSTO/URETHRAL DILATION/LEFT URS/LASER. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MEDWATCH 9610617-2025-1373.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22722319 ↗
• MalfunctionJun 21, 2025Dent in Material; Mechanical Jam; Dent in Material; Mechanical Jam

  IT WAS REPORTED THAT THE LASER FIBER NOT GOING INSIDE THE SCOPE DURING SURGERY. THE SURGICAL PROLONGATION WAS BETWEEN 15 AND 60 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303759 ↗
• MalfunctionJun 3, 2025Difficult to Insert; Difficult to Insert

  ACCORDING TO THE INFORMATION RECEIVED, THE LASER FIBER NOT GOING INSIDE THE SCOPE DURING SURGERY. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137380 ↗
• MalfunctionJun 2, 2025Erratic or Intermittent Display; No Display/Image; Erratic or Intermittent Display; No Display/Image

  ACCORDING TO THE INFORMATION RECEIVED, FLICKERED TO A BLACK SCREEN, SCOPE WE PLUGGED IN AND IMMEDIATELY HAD 1/2 LIGHT OUTPUT. IMAGE WAS VERY DARK. SWAPPED OUT TO A 2ND SCOPE BEFORE WE STARTED THE CASE. 2ND SCOPE FAILED HALFWAY THROUGH THE CASE AND THEY PUSHED FLUORO THROUGH WORKING CHANNEL WITH SYRINGE. IMAGE STARTED DIGITIZING GREEN AND PURPLE LINES, FLICKERING, AND WITHIN 30 SECONDS WENT BLACK. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126491 ↗
• MalfunctionJun 2, 2025Erratic or Intermittent Display; No Display/Image; Erratic or Intermittent Display; No Display/Image

  ACCORDING TO THE INFORMATION RECEIVED, FLICKERED TO A BLACK SCREEN, SCOPE WE PLUGGED IN AND IMMEDIATELY HAD 1/2 LIGHT OUTPUT. IMAGE WAS VERY DARK. SWAPPED OUT TO A 2ND SCOPE BEFORE WE STARTED THE CASE. 2ND SCOPE FAILED HALFWAY THROUGH THE CASE AND THEY PUSHED FLUORO THROUGH WORKING CHANNEL WITH SYRINGE....IMAGE STARTED DIGITIZING GREEN AND PURPLE LINES, FLICKERING, AND WITHIN 30 SECONDS WENT BLACK. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126477 ↗
• MalfunctionJun 2, 2025Erratic or Intermittent Display; No Display/Image; Erratic or Intermittent Display; No Display/Image

  ACCORDING TO THE INFORMATION RECEIVED, FLICKERED TO A BLACK SCREEN, SCOPE WE PLUGGED IN AND IMMEDIATELY HAD 1/2 LIGHT OUTPUT. IMAGE WAS VERY DARK. SWAPPED OUT TO A 2ND SCOPE BEFORE WE STARTED THE CASE. 2ND SCOPE FAILED HALFWAY THROUGH THE CASE AND THEY PUSHED FLUORO THROUGH WORKING CHANNEL WITH SYRINGE. IMAGE STARTED DIGITIZING GREEN AND PURPLE LINES, FLICKERING, AND WITHIN 30 SECONDS WENT BLACK. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126475 ↗
• MalfunctionMay 28, 2025No Display/Image; Optical Problem; No Display/Image; Optical Problem

  IT WAS REPORTED THAT THE IMAGE INTERFERENCE WAS PRESENT, ONLY LINES ON THE SCREEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097295 ↗
• MalfunctionMay 27, 2025Optical Obstruction; Optical Obstruction

  IT WAS REPORTED THAT DURING A URETEROSCOPY LASER LITHTRIPSY PROCEDURE THE SCOPE OBSTRUCTED IN THE WORKING CHANNEL. NO PATIENT INJURY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089627 ↗
• MalfunctionMay 12, 2025No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THERE IS A GREEN HORIZONTAL LINE FLICKERING OCCURRING RIGHT WHEN THE SCOPE IS FIRST PLUGGED IN. SOMETIMES IT GETS SO BAD WHERE THE GREEN HORIZONTAL LINES BECOME A FLASH DISRUPTION OF THE IMAGE. THIS HAS HAPPENED TO MULTIPLE SCOPES AND SOME HAVE WORSE FLICKERING OR FLASHING OF THE IMAGE. AT TIMES IT ENDS UP WHERE THE SCOPE COMPLETELY DIES AND IT GOES BACK TO THE BLUE DASHBOARD SCREEN. THEY TRIED DIFFERENT CAMERA BOXES AND DIFFERENT TC028 ADAPTERS. THE SYMPTOMS PERSISTED AND IT'S OCCURRING TO ANOTHER FACILITY WITH SIMILAR LOT CODE. THEY WERE ABLE TO COMPLETE THE PROCEDURE AFTER OPENING A NEW SCOPE WHICH WAS A REUSABLE ONE INSTEAD OF A DISPOSABLE SCOPE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REF: COMPLAINT ID: (B)(4). CROSS REF: COMPLAINT ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005847 ↗