n.a. 26055CBRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04048551275597), received between Jul 23, 2020 and Aug 5, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 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 50146858 ↗
• MalfunctionMar 30, 2026Break

  THE FOLLOWING INFORMATION WAS RECEIVED: DURING TCRF LOOP BROKE INSIDE PATIENT, THE BIPOLAR CUT WAS THEN ACTIVATED CAUSING A SPARK AND BURN/CRACK TO THE CERAMIC BEAK ON SHEATH. DARK CHARRED MARKS WERE NOTED ON FIBROIDS HOWEVER CUSTOMER SWAPPED SET AND CARRIED ON RESECTION AS NORMAL, AT THE END OF THE PROCEDURE THE DARK MARKS WERE NO LONGER PRESENT. THE BROKEN PART WAS RETRIEVED FROM THE PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. THE FOLLOWING INFORMATION WAS RECEIVED: DURING TCRF LOOP BROKE INSIDE PATIENT, THE BIPOLAR CUT WAS THEN ACTIVATED CAUSING A SPARK AND BURN/CRACK TO THE CERAMIC BEAK ON SHEATH. DARK CHARRED MARKS WERE NOTED ON FIBROIDS HOWEVER CUSTOMER SWAPPED SET AND CARRIED ON RESECTION AS NORMAL, AT THE END OF THE PROCEDURE THE DARK MARKS WERE NO LONGER PRESENT. THE BROKEN PART WAS RETRIEVED FROM THE PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR 9610617-2026-00674.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24708742 ↗
• MalfunctionFeb 18, 2026Break

  ACCORDING TO THE INFORMATION RECEIVED, DURING RESECTION OF FIBROID, LOOP BECAME DAMAGED AND THE INNER SHEATH CERAMIC BEAK WAS SUBSEQUENTLY DAMAGED, HAS DARK MARKINGS ON INSIDE, THE CERAMIC BEAK CRACKED BUT DID NOT DETACH INSIDE THE PATIENT. THUS, THEY DID NOT X-RAY. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378985 ↗
• InjuryJun 14, 2022Material Fragmentation; Break; Material Fragmentation

  AS PER MANUFACTURER INCIDENT REPORT #(B)(4) RECEIVED FROM THE FACTORY IN GERMANY: THE REPORTED EVENT HAPPENED IN SPAIN. ACCORDING TO THE INFORMATION AVAILABLE, THE CERAMIC TIP BROKE OFF INSIDE THE PATIENT, WITH A KIND OF EXPLOSION. THE PHYSICIAN HAD TO REMOVE THE PARTS FROM INSIDE THE PATIENT WITHOUT BEING SURE THAT ALL PARTS WERE COLLECTED. THERE IS NO FURTHER INFORMATION RELATED TO THE DESCRIBED EXPLOSION.

  Patient problems: Insufficient Information

  MAUDE report 14685225 ↗
• MalfunctionMay 6, 2022Material Fragmentation; Material Fragmentation

  AS PER MANUFACTURER INCIDENT REPORT #(B)(4) RECEIVED FROM THE FACTORY IN (B)(4): THE EVENT OCCURRED IN (B)(6). ACCORDING TO THE INFORMATION AVAILABLE, THE CERAMIC TIP OF THE 26055CB BROKE IN THE PATIENT'S UTERUS. A FEW OF THE BROKEN PARTS ARE STILL IN THE PATIENT'S UTERUS.

  Patient problems: Foreign Body In Patient

  MAUDE report 14311358 ↗
• MalfunctionJul 23, 2020Fracture; Fracture

  AS PER A REPORT WE RECEIVED FROM THE FACTORY IN (B)(6) IN REGARD TO AN INCIDENT THAT OCCURRED IN (B)(6): WHEN SURGEON WAS PERFORMING A TCR, AT AROUND THREE MINUTES, THEY FOUND THE CUTTING LOOP BURNING AND THE SCOPE WAS DAMAGED AND THE WHITE CERAMIC OF SHEATH ALSO BROKEN. AN X-RAY CONFIRMED EVERYTHING WAS RETRIEVED; THERE WAS NO HARM TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10314000 ↗