TROPHYscope 26008BACRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04048551276006), received between Mar 16, 2026 and Sep 8, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675844 ↗
• InjuryAug 13, 2026Break

  The following was reported: "During a hysteroscopic procedure for vaginal septum resection, the insulation sheath of the fine-tip electrode (Ref. (b)(4) melted onto the optic telescope (Ref.(b)(4) during use, and the fine tip broke off inside the uterine cavity. Use of the device was immediately discontinued, and the damaged equipment was isolated and identified. An active search was undertaken for the broken tip fragment, which was initially visualized within the uterine cavity mucosa using a 26 Ch hystero-resectoscope. Attempts to retrieve the fragment with a hysteroscope and curette were unsuccessful. At the surgeon's request, a Bettocchi hysteroscope with a small curette and grasping forceps was then used; however, the fragment could no longer be visualized. An extensive search was conducted both within the uterine cavity and throughout the operating environment, including examination of the resectoscope working channels, suction tubing, Neptune suction filter, operating room floor, surgical drapes, blood clots, and recovered tissue specimens. A plain abdominal X-ray (KUB/ASP) was performed, with no abnormal findings. The broken tip fragment could not be located or recovered.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50242718 ↗
• MalfunctionJul 10, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25782196 ↗
• MalfunctionJul 9, 2026Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25769190 ↗
• MalfunctionMay 26, 2026Optical Obstruction

  IT WAS REPORTED "OPTICAL SYSTEM: FOGGY.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25283602 ↗
• MalfunctionMar 16, 2026Poor Quality Image

  IT WAS REPORTED "OPTICAL SYSTEM: FOGGY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24611712 ↗