PRINCESS 8653204Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207018613), received between Feb 13, 2023 and Feb 13, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Ambient Noise Problem” (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.

• MalfunctionFeb 13, 2023Ambient Noise Problem; Excessive Heating; Ambient Noise Problem; Excessive Heating

  THE USER FACILITY CLAIMED THAT "SCALPEL PLATE PLACED AT THE LEVEL OF THE LEFT THIGH. PATIENT IN SUPINE POSITION, AFTER INSUFFLATION, 2 TROCARS IN PLACE, AND THE SURGEON DECIDES TO REMOVE AN ADHESION. ACTIVATION OF THE BIPOLAR FORCEPS: IMMEDIATE STOP BECAUSE OF NOISE AND VISUALIZATION OF THE BURN LOCATED ABOVE THE PUBIS / LOWER ABDOMEN (PATIENT'S LEFT SIDE). VISUAL INSPECTION OF THE OPERATING FIELD AND THE PATIENT: NO ADDITIONAL BURNS OBSERVED ON THE PATIENT." THE TREATMENT WAS CONTINUED WITH OTHER PRODUCTS AND COMPLETED WITH AN UNSPECIFIED DELAY.

  Patient problems: Insufficient Information

  MAUDE report 16366924 ↗