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PRINCESS 4653033Recalls & reported problems

Richard Wolf GmbH · HOOK ELECTRODE 21/24.5FR for hysteroscopy, for continuous irrigation sheaths, 21/ 24.5, Fr, electrode shape: hook, fork color transparent, stem color blue, PACK=3 PCS, for use in combination with the Princess resectoscope, sterile, for single use · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207053362), received between Feb 13, 2023 and Feb 13, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Disintegration” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Disintegration2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 13, 2023Material Disintegration; Material Disintegration

    THE USER FACILITY REPRESENTATIVE REPORTED THAT DURING A CASE, THE TIP OF THE HOOK ELECTRODE 21/24.5FR, PART # 4653033 BROKE OFF. THE TIP BROKE WHILE SURGEON WAS RESECTING TISSUE AROUND EMBEDDED IUD (INTRAUTERINE DEVICE) IN THE CERVIX. ACCORDING TO SURGEON, SHE PULLED OUT THE BROKEN PIECE AND IT FELL ON THE FLOOR. STAFF WAS NOT ABLE TO LOCATE THE PIECE. AN X-RAY WAS PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY REPRESENTATIVE ON JANUARY 20, 2023. ACCORDING TO THE RECEIVED INFORMATION, THERE WAS A DELAY OF 30 MINUTES TO FIND AND RETRIEVED THE BROKEN PIECE OUT OF THE PATIENT'S CERVIX. THE USER FACILITY PERFORMED AN X-RAY TO BE SURE NO FOREIGN BODY REMAINED IN THE PATIENT. THE USER FACILITY CONFIRMED THAT THE X-RAY WAS NEGATIVE. THE INTENDED SURGERY PROCEDURE WAS COMPLETED AND THE OUTCOME WAS FAVORABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16366929 ↗
  • MalfunctionFeb 13, 2023Material Disintegration; Material Disintegration

    THE USER FACILITY REPRESENTATIVE REPORTED THAT DURING A CASE, THE TIP OF THE HOOK ELECTRODE 21/24.5FR, PART # 4653033 BROKE OFF. THE TIP BROKE WHILE SURGEON WAS RESECTING TISSUE AROUND EMBEDDED IUD (INTRAUTERINE DEVICE) IN THE CERVIX. ACCORDING TO SURGEON, SHE PULLED OUT THE BROKEN PIECE AND IT FELL ON THE FLOOR. STAFF WAS NOT ABLE TO LOCATE THE PIECE. AN X-RAY WAS PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY REPRESENTATIVE ON JANUARY 20, 2023. ACCORDING TO THE RECEIVED INFORMATION, THERE WAS A DELAY OF 30 MINUTES TO FIND AND RETRIEVED THE BROKEN PIECE OUT OF THE PATIENT'S CERVIX. THE USER FACILITY PERFORMED AN X-RAY TO BE SURE NO FOREIGN BODY REMAINED IN THE PATIENT. THE USER FACILITY CONFIRMED THAT THE X-RAY WAS NEGATIVE. THE INTENDED SURGERY PROCEDURE WAS COMPLETED AND THE OUTCOME WAS FAVORABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16366925 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.