n.a. 26055GP1-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551393222), received between Sep 3, 2025 and Dec 8, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2025Detachment of Device or Device Component; Explosion; Detachment of Device or Device Component; Explosion

  THE FOLLOWING WAS REPORTED: AFTER TWO BRIEF ACTIVATIONS, THE THIRD ACTIVATION TRIGGERED A SUSPECTED EXPLOSION OF THE RESECTOSCOPE LOOP, RESULTING IN EXTENSIVE BURN MARKS INSIDE THE PATIENT'S UTERINE CAVITY. FOLLOWING THIS MALFUNCTION, THE SURGEON SWITCHED TO AN IBS (INTRAUTERINE BIG SHAVER) SYSTEM TO COMPLETE THE TREATMENT, ALONG WITH A SUBSEQUENT DILATION AND CURETTAGE. POST-PROCEDURE VISUAL INSPECTION REVEALED COMPLETE DISAPPEARANCE OF THE ACTIVE LOOP, DISCONNECTION ON THE RETURN ELECTRODE SIDE, AND NO SIGNS OF BURNING AT THE TEFLON BLOCK CONNECTING THE RESECTOSCOPE LOOP TO THE HANDPIECE. THE PATIENT IS CURRENTLY IN STABLE CONDITION AND HAS BEEN DISCHARGED. THE DEPTH OF ENDOMETRIAL DAMAGE CAUSED BY THIS INCIDENT COULD NOT BE DETERMINED. DUE TO THE INJURY (EXTENSIVE BURN MARKS) TO THE PATIENT'S UTERINE CAVITY, THIS CASE IS DEEMED REPORTABLE.

  Patient problems: Burn(s)

  MAUDE report 23744789 ↗
• InjuryDec 8, 2025Detachment of Device or Device Component; Explosion; Detachment of Device or Device Component; Explosion

  THE FOLLOWING WAS REPORTED: AFTER TWO BRIEF ACTIVATIONS, THE THIRD ACTIVATION TRIGGERED A SUSPECTED EXPLOSION OF THE RESECTOSCOPE LOOP, RESULTING IN EXTENSIVE BURN MARKS INSIDE THE PATIENT'S UTERINE CAVITY. FOLLOWING THIS MALFUNCTION, THE SURGEON SWITCHED TO AN IBS (INTRAUTERINE BIG SHAVER) SYSTEM TO COMPLETE THE TREATMENT, ALONG WITH A SUBSEQUENT DILATION AND CURETTAGE. POST-PROCEDURE VISUAL INSPECTION REVEALED COMPLETE DISAPPEARANCE OF THE ACTIVE LOOP, DISCONNECTION ON THE RETURN ELECTRODE SIDE, AND NO SIGNS OF BURNING AT THE TEFLON BLOCK CONNECTING THE RESECTOSCOPE LOOP TO THE HANDPIECE. THE PATIENT IS CURRENTLY IN STABLE CONDITION AND HAS BEEN DISCHARGED. THE DEPTH OF ENDOMETRIAL DAMAGE CAUSED BY THIS INCIDENT COULD NOT BE DETERMINED. DUE TO THE INJURY (EXTENSIVE BURN MARKS) TO THE PATIENT'S UTERINE CAVITY, THIS CASE IS DEEMED REPORTABLE.

  Patient problems: Burn(s)

  MAUDE report 23744788 ↗
• MalfunctionSep 3, 2025Material Separation; Material Separation

  IT WAS REPORTED DURING A MEDICAL PROCEDURE ON (B)(6) 2025 THE BIPOLAR CUTTING LOOP SNAPPED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22957957 ↗