n.a. 011050-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 04048551412633), received between Apr 26, 2022 and Aug 13, 2026 — classified as 23 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Break” (37 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 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50237263 ↗
• InjuryAug 11, 2026Detachment of Device or Device Component

  It was reported that three resection loops fractured during the procedure. An additional sterile resection set was opened to retrieve the broken fragment. The device malfunction resulted in a prolonged procedure and prolonged general anesthesia.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50212553 ↗
• InjuryAug 11, 2026Detachment of Device or Device Component

  It was reported that three resection loops fractured during the procedure. An additional sterile resection set was opened to retrieve the broken fragment. The device malfunction resulted in a prolonged procedure and prolonged general anesthesia.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50212547 ↗
• InjuryAug 8, 2026Break; Explosion

  According to the information received, during a hysteroscopy procedure, a 15 Fr bipolar loop ruptured (exploded) during use, making it impossible to continue the surgical procedure. It was stated that the procedure was performed only partially, according to the surgical report and the soot left in the uterus as a result of the loop rupture was aspirated, and corticosteroids plus antibiotics were administered to the patient. It was stated that the patient's hospitalization was not prolonged.

  Patient problems: Insufficient Information

  MAUDE report 50184707 ↗
• InjuryJul 27, 2026Break

  It was reported that three resection loops broke during the hysteroscopy during normal use. There was a risk of a foreign body remaining in the uterus, requiring irrigation and retrieval procedures. A new sterile package had to be opened to use another loop and recover the broken fragment. The procedure duration and the patient's generalanesthesia time were significantly prolonged. The prolongation is unknown. No negative impact in state of health reported.Version BB.MDR DQ:Following consultation with Medical & Scientific Affairs, the measures undertaken to remove the foreign body are considered a surgical intervention to prevent permanent impairment or irreversible damage if left untreated. Even so it cannot be conclusively determined whether the foreign body would have resulted in permanent impairment or irreversible damage if left untreated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50040126 ↗
• InjuryJul 27, 2026Break

  It was reported that three resection loops broke during the hysteroscopy during normal use. There was a risk of a foreign body remaining in the uterus, requiring irrigation and retrieval procedures. A new sterile package had to be opened to use another loop and recover the broken fragment. The procedure duration and the patient's generalanesthesia time were significantly prolonged. The prolongation is unknown. No negative impact in state of health reported.Version BBMDR DQ:Following consultation with Medical & Scientific Affairs, the measures undertaken to remove the foreign body are considered a surgical intervention to prevent permanent impairment or irreversible damage if left untreated. Even so it cannot be conclusively determined whether the foreign body would have resulted in permanent impairment or irreversible damage if left untreated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50040123 ↗
• MalfunctionJun 24, 2026Break; Arcing of Electrodes

  THE FOLLOWING WAS REPORTED : THAT DURING THE PROCEDURE WITH THE MINI-RESECTOR, A FLASH WAS VISIBLE ON THE MONITOR, AND THE LOOP BEING USED FOR THE PROCEDURE BROKE; HOWEVER, WE WERE ABLE TO RETRIEVE THE BROKEN PIECE. A BIPOLAR CURRENT WAS BEING USED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25613789 ↗
• 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 FRIDAY, (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: 9610617-2026-1191 9610617-2026-1192.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25281052 ↗
• MalfunctionMay 14, 2026Material Fragmentation

  IT WAS REPORTED THAT FOUR RESECTION LOOPS FRACTURED DURING THE PROCEDURE, WITH AT LEAST ONE BREAKING INSIDE THE PATIENT. ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25166920 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT "DURING A GYNECOLOGICAL RESECTION, A LOOP BROKE. THE SURGEON HAD TO REPLACE THE LOOP AND RETRIEVE THE FRAGMENTS DURING THE SAME PROCEDURE. THE PROCEDURE WAS NOT PROLONGED, AND NO X-RAYS WERE REQUIRED". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25165618 ↗
• MalfunctionMay 13, 2026Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE RESECTION LOOP BROKE INSIDE THE PATIENT. THE FRAGMENT WAS REMOVED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163702 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT "LOOP BROKE DURING PROCEDURE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25007741 ↗
• InjuryApr 24, 2026Detachment of Device or Device Component

  DURING A PROSTATE RESECTION USING THE THULEP TECHNIQUE AND THE SPECIFIC BIPOLAR RESECTION LOOP, THE LOOP BROKE INSIDE THE PATIENT WHEN THE SURGEON ATTEMPTED TO RETRIEVE A PROSTATE CHIP. THE SURGEON THEN HAD TO RECOVER THE SMALL BROKEN FRAGMENT USING A SINGLE USE FLEXIBLE FOREIGN BODY FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984435 ↗
• MalfunctionApr 16, 2026Detachment of Device or Device Component

  THIS MICRO DISSECTOR WAS TOO FRAGILE FOR THE POLYP TO BE REMOVED, AND A SECOND SNARE WAS REQUIRED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT ON THE PATIENT; THE SNARE THAT HAD BECOME MOBILE (AND THEREFORE INEFFECTIVE) WAS REPLACED, NOTHING REMAINED INSIDE THE PATIENT, AND NO ADDITIONAL INJURY OCCURRED. THE PROCEDURE WAS SLIGHTLY LONGER (BUT NEGLIGIBLE). THE ONLY CONSEQUENCE WAS THE USE OF TWO SNARES INSTEAD OF ONE FOR THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24904150 ↗
• MalfunctionApr 16, 2026Break

  THE FOLLOWING WAS REPORTED THAT DURING A MYOMECTOMY FOR A 1-CM INTRAMURAL FIBROID, WHILE USING A 5-MM RESECTOSCOPE, THE RESECTION LOOP SNAPPED AND DAMAGED THE OPTICAL SYSTEM. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24900079 ↗
• InjuryApr 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A BIPOLAR ELECTRODE FRACTURED INSIDE THE PATIENT. THE THEATRE STAFF REPORTED THAT SMALL FRAGMENTS FROM THE ELECTRODE HAD DETACHED AND REMAINED WITHIN THE PATIENT. THE PROCEDURE WAS BEING CARRIED OUT USING A B BRAUN STACK SYSTEM, A COVIDIEN BIPOLAR MACHINE. THERE WAS A DELAY LONGER THAN 60 MINUTES WHILE THEATRE STAFF WORKED TO CONFIRM THAT ALL FRAGMENTS HAD BEEN SUCCESSFULLY RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889539 ↗
• InjuryApr 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A BIPOLAR ELECTRODE FRACTURED INSIDE THE PATIENT. THE THEATRE STAFF REPORTED THAT SMALL FRAGMENTS FROM THE ELECTRODE HAD DETACHED AND REMAINED WITHIN THE PATIENT. THE PROCEDURE WAS BEING CARRIED OUT USING A B BRAUN STACK SYSTEM, A COVIDIEN BIPOLAR MACHINE. THERE WAS A DELAY LONGER THAN 60 MINUTES WHILE THEATRE STAFF WORKED TO CONFIRM THAT ALL FRAGMENTS HAD BEEN SUCCESSFULLY RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888700 ↗
• InjuryApr 15, 2026Detachment of Device or Device Component

  DURING A PROSTATE RESECTION USING THE THULEP TECHNIQUE AND THE SPECIFIC BIPOLAR RESECTION LOOP, THE LOOP BROKE INSIDE THE PATIENT WHEN THE SURGEON ATTEMPTED TO RETRIEVE A PROSTATE CHIP. THE SURGEON THEN HAD TO RECOVER THE SMALL BROKEN FRAGMENT USING A SINGLE USE FLEXIBLE FOREIGN BODY FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887201 ↗
• MalfunctionMar 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRODUCT BROKE INTO THE PATIENT. HOWEVER, NO INFORMATION ABOUT IF PRODUCT WAS RECOVERED AND THERE IS NO INFORMATION ABOUT HARM OR INJURY TO PATIENT REPORTED. THEREFORE, THIS CASE IS REPORTABLE AS PRECAUTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24708754 ↗
• MalfunctionMar 20, 2026Break

  "THE FOLLOWING WAS REPORTED: "THE SURGEON WAS PERFORMING AN ENDOMETRIECTOMY (A RESECTION OF SOFT TISSUE, NOT A HARD STRUCTURE LIKE A FIBROID), AND THE LOOP BROKE THREE TIMES INSIDE THE UTERUS. THE SURGEON LEFT THE OPERATING ROOM TO RETRIEVE A BETOCCHI HYSTEROSCOPE SET, AS IT CONTAINS FORCEPS THAT ALLOW RETRIEVAL OF THE METAL FRAGMENT LEFT INSIDE THE UTERUS. THE PROCEDURE CONTINUED WITH THE SAME HYSTEROSCOPE AFTER CHANGING THE LOOP THREE TIMES (EACH ONE BREAKING AGAIN), DUE TO DIFFICULTIES IN OBTAINING ADDITIONAL HYSTEROSCOPE SETS THAT DAY, AS THEY WERE STILL IN THE STERILIZATION PROCESS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED."

  Patient problems: Insufficient Information

  MAUDE report 24654739 ↗
• InjuryMar 13, 2026Break

  THE FOLLOWING WAS REPORTED: DURING AN OPERATIVE HYSTEROSCOPY, A 5 MM RESECTION LOOP REF. (B)(4) (LOT NO. 858491, EXP 30.11.2029) BROKE DURING THE PROCEDURE. THE SURGEON PERFORMED A VERIFICATION ENDOSCOPICALLY, DIGITALLY, AND VISUALLY, BUT THE LOOP WAS NOT FOUND. DUE TO THE FACT THAT FRAGMENTS OR BROKEN PARTS MAY HAVE BEEN LEFT BEHIND IN THE PATIENT, THIS CASE IS DEEMED REPORTABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24599378 ↗
• 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: 9610617-2026-00555.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24587963 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT "THE 011050-10 HAD EXPLODED". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483251 ↗
• MalfunctionFeb 4, 2026Sparking

  IT WAS REPORTED THAT "HYSTEROSCOPIC RESECTION OF A UTERINE POLYP AND FIBROID PERFORMED ON 13/01 IN THE OPERATING ROOM. A 15CH BIPOLAR RESECTOSCOPE WAS CORRECTLY ASSEMBLED (ASSEMBLY VERIFIED). GENERATOR UNIT IN PLACE. INTRODUCTION OF THE RESECTOSCOPE. RESECTION OF TWO CHIPS CAUSED SPARKS, LEADING TO THE IMMEDIATE INTERRUPTION OF THE PROCEDURE AND REMOVAL OF THE RESECTOSCOPE. CONSEQUENCES: A NEW LOOP FROM ANOTHER LOT WAS USED, AND THERE WERE NO ISSUES WITH THIS NEW LOOP. EXTENSION OF THE OPERATING TIME BY 10 MINUTES. THE PATIENT WAS DOING WELL IN THE IMMEDIATE POSTOPERATIVE PERIOD." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264852 ↗
• InjuryJan 30, 2026Detachment of Device or Device Component

  THE EVENT OCCURRED IN GREAT BRITAIN. IT WAS REPORTED THAT THE DISTAL TIP OF THE CUTTING LOOP HAS MELTED/BURNT OFF. DURING THE PROCEDURE, THE INSTRUMENT WAS CONNECTED TO THE RESECTOSCOPE AND THE RESECTOSCOPE WAS THEN CONNECTED TO THE GENERATOR FOR USE. DURING USE THE SPARKS WERE OBSERVED AT THE DISTAL TIP OF THE INSTRUMENT AND THE INSTRUMENT WAS THEN REMOVED FROM THE PATIENT. IT WAS THEN OBSERVED THAT THE DISTAL TIP OF THE ELECTRODE HAD BURNT/MELTED AND PIECES WERE MISSING. THE CLINICIAN THEN HAD A LOOK IN THE CAVITY FOR ANY BROKEN COMPONENTS BUT WAS UNABLE TO IDENTIFY ANYTHING. AN X-RAY WAS REQUESTED AND COMPLETED, HOWEVER THIS SHOWED NOTHING INSIDE THE PATIENT. THIS CAUSED A DELAY OF ROUGHLY 60 MINUTES. THE PROCEDURE WAS THEN CONCLUDED AND NOT COMPLETE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220610 ↗