n.a. 26055EBRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04048551258309), received between Nov 4, 2024 and Aug 5, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fitting Problem” (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.

• MalfunctionAug 5, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50146857 ↗
• InjuryJul 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RESECTOSCOPE HAD BEEN USED APPROXIMATELY TWICE WHEN IT CAME APART, GIVING THE IMPRESSION OF A DEFECTIVE WELD. THE INCIDENT WAS DETECTED DURING THE SECOND USE. THE CUSTOMER INDICATES THAT THE WORKING ELEMENT ENTERS THE PATIENT THROUGH THE DISTAL TIP; HOWEVER, ON THE HANDLE SIDE IT DOES NOT EXTEND INTO THE PATIENT, AND THIS IS THE AREA WHERE THE COMPONENT BECAME DETACHED. ACCORDING TO THE NEW INFORMATION, RECEIVED ON (B)(6) 2026, THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE THEY GRADUALLY NOTICED THAT THE COMPONENT WAS BECOMING DETACHED. THE DETACHMENT DID NOT OCCUR SUDDENLY. AS A RESULT, THE GYNECOLOGIST WAS UNABLE TO COMPLETE THE RESECTION, AND THE COMPONENT BECAME FULLY DETACHED WHEN THE RESECTOSCOPE WAS WITHDRAWN AT THE END OF THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS; HOWEVER, THE MYOMA COULD NOT BE COMPLETELY RESECTED. THEREFORE, IT IS LIKELY THAT THE PATIENT WILL REQUIRE AN ADDITIONAL MEDICAL PROCEDURE TO ACHIEVE COMPLETE RESECTION OF THE MYOMA.

  Patient problems: Insufficient Information

  MAUDE report 25895007 ↗
• InjuryJul 25, 2025Fitting Problem; Misassembly During Maintenance/Repair; Fitting Problem; Misassembly During Maintenance/Repair

  IT WAS REPORTED AS FOLLOWS: INTRAOPERATIVELY THE SURGEON WAS USING A 22FR BIPOLAR WORKING ELEMENT THAT HAD BEEN REPAIRED BY A THIRD PARTY. THIS REPAIR CHANGED THE DIMENSIONS OF THE WORKING ELEMENT WHICH SUBSEQUENTLY WOULD NOT INTERLOCK WITH THE INNER AND OUTER SHEATH. ONLY ONE OF THESE ITEMS WAS AVAILABLE IN THE HOSPITAL. AN ALTERNATIVE SIZE WAS OFFERED TO THE SURGEON (26FR) HOWEVER THIS WAS NOT AN APPROPRIATE SIZE FOR THE PATIENT AND THE CASE WAS ABORTED. THE PATIENT WAS AWOKEN OUT OF ANESTHESIA AND REBOOKED FOR A FUTURE DATE. THE PROCEDURE IS RESECTION OF POLYPS. SINCE THE PROCEDURE WAS ABORTED, THE CASE IS DEEMED AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610579 ↗
• InjuryJul 25, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED AS FOLLOWS: INTRAOPERATIVELY THE SURGEON WAS USING A 22FR BIPOLAR WORKING ELEMENT THAT HAD BEEN REPAIRED BY A THIRD PARTY. THIS REPAIR CHANGED THE DIMENSIONS OF THE WORKING ELEMENT WHICH SUBSEQUENTLY WOULD NOT INTERLOCK WITH THE INNER AND OUTER SHEATH. ONLY ONE OF THESE ITEMS WAS AVAILABLE IN THE HOSPITAL. AN ALTERNATIVE SIZE WAS OFFERED TO THE SURGEON (26FR) HOWEVER THIS WAS NOT AN APPROPRIATE SIZE FOR THE PATIENT AND THE CASE WAS ABORTED. THE PATIENT WAS AWOKEN OUT OF ANESTHESIA AND REBOOKED FOR A FUTURE DATE. THE PROCEDURE IS RESECTION OF POLYPS. SINCE THE PROCEDURE WAS ABORTED, THE CASE IS DEEMED AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610576 ↗
• InjuryNov 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A "FLUID LEAKAGE WAS OBSERVED DURING BIPOLAR RESECTION OF UTERINE POLYPS. THE LEAKAGE WAS SO INTENSE THAT THE PROCEDURE HAD TO BE INTERRUPTED. POLYPS WERE NOT REMOVED. THE LEAK OCCURRED FROM THE SHEATH AND THE WORKING ELEMENT. THE PROCEDURE HAS NOT BEEN COMPLETED". NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20599987 ↗