n.a. 26053SCRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04048551410462), received between May 23, 2025 and Jun 2, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Leak/Splash

  IT WAS REPORTED THAT THE SHEATH WAS LEAKING DURING USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25366155 ↗
• MalfunctionMar 10, 2026Leak/Splash

  IT WAS REPORTED THAT "LEAK ISSUE ON THE RESECTOSCOPE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24565479 ↗
• MalfunctionJul 28, 2025Mechanical Problem; Melted; Mechanical Problem

  ACCORDING TO THE INFORMATION RECEIVED, THE BAKELITE COMPONENT OF THE 15FR RESECTOSCOPE'S GOT DAMAGED WHEN INSIDE PATIENT AND THE ELECTRODE TIP WAS BURNED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22627016 ↗
• InjuryMay 23, 2025Optical Problem; Optical Problem

  ACCORDING TO THE INFORMATION RECEIVED, THE 15FR RESECTOR HANDLE EXPLODED INSIDE THE PATIENT, BURNING THE OPTICS AND DAMAGING THE 26053CB SHEATH. BOTH THE WORKING ELEMENT AND THE CABLE HAVE BEEN FOUND TO BE IN PERFECT CONDITION. FORTUNATELY, THE PATIENT HAS NOT BEEN HARMED. ACCORDING TO THE INFORMATION RECEIVED, THERE WAS A VISIBLE SPARK WHILE INSIDE THE PATIENT, THE PHYSICAL STRUCTURE OF THE APPARATUS (THE INSULATION OF THE SHEATH) BROKE, AND DEBRIS WERE FOUND INSIDE THE PATIENT. THESE DEBRIS WERE REMOVED FROM THE PATIENT BEFORE SURGERY WAS COMPLETED. ALSO, ADDITIONAL INTERVENTION REQUIRED TO REMOVE THE BROKEN PART DURING THE SURGERY. THEREFORE, THIS CASE IS AN INJURY AND REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080597 ↗
• MalfunctionMay 23, 2025Material Deformation; Optical Problem; Material Deformation; Optical Problem

  ACCORDING TO THE INFORMATION RECEIVED, THE 15FR RESECTOR HANDLE EXPLODED INSIDE THE PATIENT, BURNING THE OPTICS AND DAMAGING THE 26053CB SHEATH. BOTH THE WORKING ELEMENT AND THE CABLE HAVE BEEN FOUND TO BE IN PERFECT CONDITION. FORTUNATELY, THE PATIENT HAS NOT BEEN HARMED. ACCORDING TO THE INFORMATION RECEIVED, THERE WAS A VISIBLE SPARK WHILE INSIDE THE PATIENT, THE PHYSICAL STRUCTURE OF THE APPARATUS (THE INSULATION OF THE SHEATH) BROKE, AND DEBRIS WERE FOUND INSIDE THE PATIENT. THESE DEBRIS WERE REMOVED FROM THE PATIENT BEFORE SURGERY WAS COMPLETED. ALSO, ADDITIONAL INTERVENTION REQUIRED TO REMOVE THE BROKEN PART DURING THE SURGERY. THEREFORE, THIS CASE IS AN INJURY AND REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080460 ↗