MAUDE Adverse Event Report: RICHARD WOLF GMBH PRINCESS; CUTTING ELECTRODE BIPO 21FR

Model Number	46531313
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
During the investigation by the specialist department, it was determined that the bipo 21fr 46531313 cutting electrode is not defective.The supplied passive mono/bipo working element 8653224, batch 1578541, shows signs of contamination inside the locking body as well as traces of an arc from the electrode lock to the yoke.The 20196-119 bipolar cable; tur/tcr; wolf is damaged and torn in several places.An examination of the cutting electrode reveals no systematic defects from a manufacturing or design perspective.Based on the results described above, there is no defect.The cause of the arc is most likely attributable to the working element, as this is contaminated inside the locking body and has caused an arc from the electrode lock to the yoke.In general, the user is advised in the user manual ga-d349, under chapter 8, that a visual and functional check must be carried out before and after each use.Potential damage or functional impairments can be easily identified by hospital staff if these instructions are followed.Furthermore, the user is advised of the device's strength limits in section 7 - 'use' - and of the danger associated with activating the electrode within an air or gas bubble (e.G.Bladder roof), as well as of the incorrect selection of hf output power in section 7.2.5 - 'hf application' (monopolar / bipolar).Safety instructions are also clearly described in section 7.2.5.2 - 'hf application (bipolar)' regarding caution in the event of excessive hf voltage or power, thermal damage and distal wear of the electrode due to continuous activation of the bivap electrode, as well as increased electrode wear caused by an excessively high power setting.In the risk assessment p08f0015 (risk assessment 882-3 non-reusable resection electrodes rev 05), the potential risks arising from failure were assessed in terms of the extent of damage, the assumed probability of occurrence and the probability of failure and were deemed acceptable.

• Brand Name: PRINCESS
• Common Device Name: CUTTING ELECTRODE BIPO 21FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 24888735
• Report Number: 9611102-2026-00014
• Device Sequence Number: 13247470
• Product Code: FAS
• UDI-Device Identifier: 04055207048962
• UDI-Public: 04055207048962
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 46531313
• Device Catalogue Number: 46531313
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 20196-119 BIPOLAR CABLE; BIPO WORKING ELEMENT 8653224; ERBE GENERATOR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown