PRINCESS 46531313Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04055207048962), received between Jul 15, 2020 and Apr 15, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING A HYSTEROSCOPY PROCEDURE, AN UNUSUAL EFFECT OCCURRED AT THE PROXIMAL END OF THE ELECTRODE (THE PART CONNECTED TO THE WORKING ELEMENT), DUE TO A SUDDEN AND UNCONTROLLED ELECTRICAL EVENT. THIS INCIDENT WAS NOT PRECEDED BY ANY NOTICEABLE IRREGULARITIES IN THE FUNCTIONING OF THE EQUIPMENT. THE PROCEDURE WAS IMMEDIATELY STOPPED WHEN THE EVENT OCCURRED. THERE ARE NO REPORTS OF INJURIES TO THE PATIENT. HOWEVER, THE OPERATOR REPORTED A SLIGHT SCORCHING ON THEIR GLOVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888735 ↗
• MalfunctionJan 27, 2026Melted

  IT WAS REPORTED THAT DURING A HYSTEROSCOPIC FIBROID REMOVAL, THE ELECTRODE MELTED AND BROKE INTO SEVERAL PIECES. THERE ARE NO REPORTS OF INJURIES OR UNACCEPTABLE RISKS, AND THE PLANNED PROCEDURE WAS SUCCESSFULLY PERFORMED USING A BACKUP DEVICE. HOWEVER, THE ISSUE CAUSED A NON-CRITICAL DELAY OF APPROXIMATELY 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193485 ↗
• MalfunctionNov 9, 2022Material Disintegration; Material Disintegration

  RWMIC REFERENCE COMPLAINT NO. (B)(4). ON OCTOBER 20, 2022, RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) RECEIVED A MEDSUN MANDATORY AND VOLUNTARY REPORT # (B)(4) REGARDING PRODUCT ID# 46531313, LOT#21003675. DESCRIPTION OF EVENT: THE TIP OF THE LOOP (WIRE PART) NOTED MISSING, MAY HAVE DISINTEGRATED. CURRENTLY, REQUESTS FOR ADDITIONAL INFORMATION FROM THE USER FACILITY HAVE BEEN UNSUCCESSFUL. RWMIC MDR AWARENESS DATE: 20-OCT-2022.

  Patient problems: Insufficient Information

  MAUDE report 15760364 ↗
• MalfunctionNov 9, 2022Material Disintegration; Material Disintegration

  RWMIC REFERENCE COMPLAINT NO. (B)(4). ON OCTOBER 20, 2022, RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) RECEIVED A MEDSUN MANDATORY AND VOLUNTARY REPORT # 2211900000-2022-8008 REGARDING PRODUCT ID# 46531313, LOT#21003675. DESCRIPTION OF EVENT: THE TIP OF THE LOOP (WIRE PART) NOTED MISSING, MAY HAVE DISINTEGRATED. CURRENTLY, REQUESTS FOR ADDITIONAL INFORMATION FROM THE USER FACILITY HAVE BEEN UNSUCCESSFUL. RWMIC MDR AWARENESS DATE: 20-OCT-2022.

  Patient problems: Insufficient Information

  MAUDE report 15760347 ↗
• MalfunctionOct 21, 2022Component Missing

  THE TIP OF THE LOOP (WIRE PART) NOTED MISSING, MAY HAVE DISINTEGRATED.

  Patient problems: Insufficient Information

  MAUDE report 15645289 ↗
• MalfunctionSep 22, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  RICHARD WOLF GMBH COMPLAINT REFERENCE NUMBER: (B)(4). THE HOSPITAL INFORMED RICHARD WOLF GMBH OF THE FOLLOWING: THE PATIENT PRESENTED FOR SURGICAL HYSTEROSCOPY FOR HYPERMENORRHOEA. ABLATION OF A SUBMUSCULAR MYOMA. DURING THE PROCEDURE, HALF OF THE RESECTION LOOP WAS TORN OFF: DURING THE FIRST INCISION AT THE MYOMA NODAL STALK AND PULLING BACK THE LOOP INTO THE WORKING CHANNEL. THE OPERATION TIME WAS EXTENDED BY 1.5 HOURS. IN ADDITION, AN X-RAY ABDOMEN SURVEY AND A HYSTEROSCOPY WERE PERFORMED. RWGMBH AWARENESS DATE, 26-AUG-2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Non-malignant Neoplasm

  MAUDE report 15463564 ↗
• MalfunctionJul 29, 2021Material Fragmentation; Material Fragmentation

  THE PURPOSE OF THIS SUBMISSION IT TO PROVIDE FDA WITH THE CORRECT PRODUCT HISTORY EVALUATION. THE ONE PREVIOUSLY SUBMITTED (FU 2) WAS INCORRECT. THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE PRODUCT HISTORY EVALUATION. THE DEVICE WAS NOT RETURNED TO RW SO AN INVESTIGATION REPORT - PRODUCT HISTORY EVALUATION WAS COMPLETED. THE MANUFACTURER, RW GMBH, REPORTS THAT: "IN THE PAST THREE YEARS (>01/01/2018), RICHARD WOLF GMBH HAS RECEIVED 4 COMPLAINTS INCLUDING THE CURRENT COMPLAINT ((B)(4)) REGARDING THE 46531313 CUTTING ELECTRODE BIPO 21 FR WITH VARIOUS DAMAGES AND CAUSES OUTSIDE THE USA. THE AFFECTED BATCH #21001965 HAS CONTAINED (B)(4) PIECES WHICH WERE PRODUCED ON 11/18/2019. ACCORDING TO THE CERTIFICATE OF COMPLIANCE, ALL (B)(4) PIECES OF THE BATCH #21001965 MEET THE REQUIRED SPECIFICATION PRIOR TO RELEASE AND THERE WERE NO NONCONFORMANCES. RWMIC HAS RECEIVED FROM THE BATCH #21001965: - 10 PIECES ON 11/16/2020; - 75 PIECES ON 11/23/2020; - 6 PIECES ON 12/10/2020. WHEN THE DEVICE IN QUESTION WAS DELIVERED TO THE CUSTOMER IS UNKNOWN BY RW GMBH. THERE WAS NO OTHER COMPLAINT FROM THE AFFECTED BATCH. THREE COMPLAINTS INCLUDING THE CURRENT COMPLAINTS ARE FROM THE US: (B)(

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249615 ↗
• MalfunctionJul 22, 2021Material Fragmentation; Material Fragmentation

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE PRODUCT HISTORY EVALUATION. THE DEVICE WAS NOT RETURNED TO RW SO AN INVESTIGATION REPORT - PRODUCT HISTORY EVALUATION WAS COMPLETED. THE MANUFACTURER, RW GMBH, REPORTS THAT: "IN THE PAST THREE YEARS (>01/01/2018), RICHARD WOLF GMBH HAS RECEIVED 4 COMPLAINTS INCLUDING THE CURRENT COMPLAINT (B)(4) REGARDING THE 46221313 CUTTING ELECTRODE BIPO 24 FR 12/30° WITH VARIOUS DAMAGES AND CAUSES OUTSIDE THE USA. THE AFFECTED BATCH #4500277056 HAS CONTAINED (B)(4) PIECES WHICH WERE PRODUCED ON 06/17/2019. ACCORDING TO THE CERTIFICATE OF COMPLIANCE, ALL (B)(4) PIECES OF THE BATCH #4500277056 MEET THE REQUIRED SPECIFICATION PRIOR TO RELEASE AND THERE WERE NO NONCONFORMANCES. RWMIC HAS RECEIVED FROM THE BATCH #4500277056: (B)(4) PIECES ON 11/15/2019, (B)(4) PIECES ON 11/19/2019 WHEN THE DEVICE IN QUESTION WAS DELIVERED TO THE CUSTOMER IS UNKNOWN BY RW GMBH. THERE WAS NO OTHER COMPLAINT FROM THE AFFECTED BATCH. THREE COMPLAINTS INCLUDING THE CURRENT COMPLAINTS ARE FROM THE US: (B)(4) - 7/14/2020, (B)(4) - 7/13/2021 (CURRENT COMPLAINT), (B)(4) - 7/13/2021. THE REPORTED DAMAGES OF THESE COMPLAINTS ARE SIMILAR: THE LOOP BROKE DURING A PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12213052 ↗
• MalfunctionJul 17, 2020Material Deformation; Material Deformation

  FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH MISSING INFORMATION, NEW INFORMATION, AND/OR CHANGED INFORMATION. PLEASE REFER TO THE MANUFACTURERS NARRATIVE FOR DETAILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10289878 ↗
• MalfunctionJul 15, 2020Material Deformation; Material Deformation

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE PRODUCT HISTORY EVALUATION. THE MANUFACTURER REPORTS: ""WITHIN THE LAST THREE YEARS (>09.01.2018) RICHARD WOLF GMBH RECEIVED ONLY ONE COMPLAINT WITH THIS PRODUCT. DURING THE SAME TIME MORE THAN (B)(4)PACKS (3 PIECES/PACK) HAVE BEEN SOLD WORLDWIDE. THE RECEIVED INVESTIGATION COMPLAINT WAS FROM A FRENCH CUSTOMER AND WAS RECEIVED IN (B)(6) 2021 - THE INVESTIGATION SHOWED THAT THE DISTAL WIRE WAS BENT AND THE INSULATING TUBE WAS PUSHED FORWARD TOGETHER WITH THE GUIDE TUBE. BECAUSE OF THAT AN ELECTRICAL SHORTCUT WAS CAUSED. ROOT CAUSE WAS DETERMINED AS A USER ERROR. ACCORDING TO OUR EXPERIENCE EXCESSIVE POWER SETTINGS ON THE HF GENERATOR CAN LEAD TO RAPID WEAR AND TEAR WHICH LEADS TO BREAKAGES OF DISTAL PARTS. TO AVOID SUCH DAMAGES DURING HF APPLICATION THE USER IS ADVISED IN THE INSTRUCTION MANUAL GA-D349 WITH SEVERAL NOTES ABOUT THE DANGERS OF MONOPOLAR AND BIPOLAR USE. IF THE POWER SETTING IS TOO HIGH ABOVE THE VALUE RECOMMENDED BY THE MANUFACTURER THERE IS A RISK OF INCREASED THERMAL DAMAGE AND ABRASION AS WELL AS BREAKAGE OF THE ELECTRODE LOOP (WIRE). DUE TO AN INCORRECTLY SELECTED HF OUTPUT POWER INJURIES TO THE PATIEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10276332 ↗