n.a. 26159GCRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551094327), received between Jul 2, 2025 and Jul 2, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT DURING THE HYSTEROSCOPY, IN ORDER TO CUT OUT THE ENDOMETRIAL POLYP, THE TIP OF ELECTRODE EXPLODED INTO FEW PIECES INSIDE OF THE UTERUS. A MICROGRASPER WAS USED TO EVACUATE SOME OF THEM. BECAUSE OF PRESSURE OF LIQUID INSIDE OF THE UTERUS, THERE IS A CHANCE THAT SOME OF THE PIECES WENT THROUGH THE TUBES INTO THE DOUGLAS POUCH. IT WAS REPORTED THAT PATIENT HAS NO PROBLEMS AFTER SURGERY. AS IT CANNOT BE EXCLUDED THAT SOME PIECES REMAINED IN THE PATIENT'S BODY, THE CASE IS DEEMED PRECAUTIONARY REPORTABLE. NOTE: THE CUSTOMER DID NOT PROVIDE THE ARTICLE NUMBER OF THE AFFECTED DEVICE. IT WAS ONLY REPORTED THAT IT WAS A BIPOLAR BALL ELECTRODE 5 FR. WITHOUT FURTHER INFORMATION IT CANNOT BE DETERMINED WHICH IS THE EXACT ARTICLE AFFECTED AND IF IT WAS EVEN A KARL STORZ ARTICLE.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 22387231 ↗