n.a. 26053CBRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04048551410479), received between Jun 16, 2021 and Jun 16, 2026 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED UPON USING THE 5MM GYNAE RESECTOSCOPE FOR TCRF CASE THE LOOP BROKE AND CAUSED A SPARK WHICH HAS CAUSED THE CERAMIC TIP OF INNER SHEATH TO BREAK OFF/DETACH INSIDE THE PATIENT. ALL PARTS WERE RETRIEVED AND THE PROCEDURE WAS STILL COMPLETED. UTERUS LOOKED BURNT/BLACK IN PARTS INSIDE WHEN USING NORMAL HYSTEROSCOPE TO CONTINUE THE PROCEDURE AND RETRIEVE LOST END OF ELECTRODE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25527181 ↗
• MalfunctionJun 9, 2026Break

  IT HAS BEEN REPORTED THAT A PIECE BROKE OFF FROM THE INNER SHAFT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25451609 ↗
• MalfunctionMay 26, 2026Detachment of Device or Device Component

  THE CUSTOMER INFORMED THE SALES REPRESENTATIVE THAT THEY EXPERIENCED AN ISSUE WITH THE SIZE 15 RESECTOR ON (B)(6) 2026. DURING A MEDICAL PROCEDURE, WHILE USING IT ON A PATIENT, TWO LOOP EXPLOSIONS OCCURRED. FORTUNATELY, THE PATIENT DID NOT SUFFER ANY HARM. WITH THE FIRST EXPLOSION, THE BAKELITE COMPONENT WAS NOT DAMAGED; HOWEVER, WITH THE SECOND LOOP USED (NEW), BROKE. IN ORDER TO CONTINUE WITH THE MEDICAL PROCEDURE, A THIRD LOOP WAS USED, WHICH FUNCTIONED CORRECTLY. THEREFORE, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CROSS REFERENCE MDR: 9610617-2026-1190; 9610617-2026-1191.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25281170 ↗
• MalfunctionApr 22, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CERAMIC TIP BROKE OFF DURING PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960794 ↗
• MalfunctionApr 22, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CERAMIC TIP BROKE OFF DURING PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960793 ↗
• MalfunctionApr 22, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CERAMIC TIP BROKE OFF DURING PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960792 ↗
• MalfunctionMar 13, 2026Material Fragmentation

  ACCORDING TO THE INFORMATION RECEIVED, THE CUSTOMER USES 15 FR. BIPOLAR RESECTOSCOPE SET WITH AUTOCON III DURING OPERATIVE HYSTEROSCOPY. THE INNER SHEATH OF THE RESECTOSCOPE AND THE BIPOLAR CUTTING ELECTRODE WERE BROKEN. ALL PIECES WERE SUCCESSFULLY RETRIEVED DURING THE SAME SURGERY WITH HYSTEROSCOPY. NO ADDITIONAL INTERVENTION WAS REQUIRED TO RETRIEVE THE PARTS. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR 9610617-2026-00554.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24587964 ↗
• MalfunctionDec 1, 2025Break; Material Fragmentation; Detachment of Device or Device Component; Break; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LOOP AND TIP OF BIPOLAR ELECTRODE HAVE DETACHED FROM THE END DURING THE GYNAECOLOGY RESECTION PROCEDURE. THE BROKEN FRAGMENT WAS COMPLETELY RETRIEVED FROM THE PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23689236 ↗
• MalfunctionNov 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, CERAMIC HAS BECOME DETACHED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618842 ↗
• InjuryNov 20, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE INFORMATION RECEIVED, DURING THE PROCEDURE, OPERATION WAS GOING FINE. DURING CUTTING THE POLYP, THERE WAS A FLASH INSIDE THE PATIENT AND THE LOOP UNEXPECTEDLY DISINTEGRATED WHILST IN USE, FRAGMENTS EMBEDDED INTO THE UTERUS WALL. SOME FRAGMENTS WERE RECOVERED. X-RAY WAS TAKEN. THE PATIENT WILL POSSIBLY HAVE TO HAVE MORE SURGERY TO FULLY REMOVE FRAGMENTS. AUTOCON III ON SETTINGS 2 CON AND 2 CUT, UH801 BIPOLAR CABLE USE, WITH 4 USES LEFT. CROSS REFERENCE MDR: 9610617-2025-01826.

  Patient problems: Foreign Body In Patient

  MAUDE report 23610533 ↗
• InjuryJun 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, DURING THE RESECTION, THE LOOP OF THE RESECTOSCOPE BROKE, AND A SMALL FRAGMENT OF THE CERAMIC FROM THE INNER SHEATH ALSO FRACTURED. THE CERAMIC FRAGMENT WAS NOT FOUND IN THE CAVITY, THE SUCTION, OR THE CLOTS. IT IS LIKELY THAT IT WAS EXPELLED AND NOT RECOVERED DUE TO ITS SMALL SIZE, BUT THIS CANNOT BE CONFIRMED WITH CERTAINTY. SINCE THE BROKEN PART COULD NOT BE FOUND AND POTENTIAL X RAY IS REQUIRED, THIS CASE IS REPORTABLE.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 22309456 ↗
• InjuryMar 25, 2025Sparking; Sparking

  THE FOLLOWING WAS REPORTED: "DURING A PROCEDURE, THE CUTTING LOOP OF STORZ 15FR RESECTOSCOPE SPARKED AND DISINTEGRATED DURING A HYSTEROSCOPIC MYOMECTOMY, CREATING A GREY SEDIMENT INSIDE THE UTERUS. THE SURGEON NOTICED THE LOSS/LACK OF CERAMIC TIP ON THE SHEATH OF THE INSTRUMENT AND WAS NOT CERTAIN IF THE TIP BROKE BEFORE OR DURING THE CASE." ADDITIONAL INFORMATION RECEIVED ON 2025-03-10 REGARDING THE PATIENT CONDITION: "THE PATIENT SUFFERED AN INJURY TO THE UTERUS, WHICH CAUSED THE GREY SEDIMENTS. THE PATIENT WILL REQUIRE A SECOND OPERATION IN 4 TO SIX WEEKS TO CHECK FOR UTERINE ADHESIONS."

  Patient problems: Insufficient Information

  MAUDE report 21691037 ↗
• InjuryMar 25, 2025Break; Break

  THE FOLLOWING WAS REPORTED: "DURING A PROCEDURE, THE CUTTING LOOP OF STORZ 15FR RESECTOSCOPE SPARKED AND DISINTEGRATED DURING A HYSTEROSCOPIC MYOMECTOMY, CREATING A GREY SEDIMENT INSIDE THE UTERUS. THE SURGEON NOTICED THE LOSS/LACK OF CERAMIC TIP ON THE SHEATH OF THE INSTRUMENT AND WAS NOT CERTAIN IF THE TIP BROKE BEFORE OR DURING THE CASE." ADDITIONAL INFORMATION RECEIVED ON 2025-03-10 REGARDING THE PATIENT CONDITION: "THE PATIENT SUFFERED AN INJURY TO THE UTERUS, WHICH CAUSED THE GREY SEDIMENTS. THE PATIENT WILL REQUIRE A SECOND OPERATION IN 4 TO SIX WEEKS TO CHECK FOR UTERINE ADHESIONS."

  Patient problems: Burn(s); Insufficient Information

  MAUDE report 21689181 ↗
• MalfunctionSep 26, 2024Break; Break

  IT WAS REPORTED THAT THE "CERAMIC RESECTOSCOPE SHEATH BROKE" DURING PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20315389 ↗
• MalfunctionJun 16, 2021Break; Break

  DURING A HYSTEROSCOPY RESECTION OF A POLYP, AFTER A FEW MINUTES OF INTERVENTION, IT THERE WAS AN INTRAUTERINE SPARK BETWEEN THE SHIRT AND HANDLE. OBSERVED BREAKAGE OF THE HANDLE RESECTION, AND CERAMIC PROTECTION (BAKELITE SHIRT), BURN OF THE OPTIC. GESTURE WAS ARRESTED IMMEDIATELY. FRAGMENTS OF THE HANDLE AND THE SLEEVE REMAINED INTRAUTERINE WITHOUT THE POSSIBILITY OF REMOVING THEM. THE PATIENT HAS BEEN WARNED. GENERATOR SETTINGS IRRIGATION AND RESECTION ARE CLASSIC AND USED FOR EACH INTERVENTION OF THE SAME TYPE NO IMMEDIATE CONSEQUENCES BUT RISK LONG-TERM POTENTIAL (TRAUMATIC? INFECTIOUS?) SINCE THE PIECES OF CERAMIC OF THE SHIRT AS WELL AS THE METAL END OF THE HANDLE COULD NOT BE FOUND.

  Patient problems: Foreign Body In Patient

  MAUDE report 12008990 ↗