MAUDE Adverse Event Report: RICHARD WOLF GMBH E-LINE/PRINCESS; CUTTING ELECTRODE BIPO 21FR

Model Number	46531313
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Non-malignant Neoplasm (4842)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Richard wolf medical instruments corporation (rwmic) is submitting this report on behalf of rwgmbh.Rwgmbh considers this matter open.However, in the event rwgmbh receives any additional information a follow up report will be submitted to fda.
Event or Problem Description
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.
Additional Manufacturer Narrative
Additional information was received from the user facility that the erbe vio 300d generator with a bip cut+ 4 setting was used.It was also stated that the tear occurred during the first incision.The patient's condition after the application was described as good.During the inspection of the cutting electrode bipo 21fr 46531313, batch # 21003482 by richard wolf gmbh, the insulation shows a black discoloration and suggests a thermal influence, however the broken edge of the electrode looks shiny and smooth with no discoloration which indicates a potential mechanical overload of the wire hanger.The hf generator and the power setting specified by the user are in general principle suitable for this type of resection snare and correspond to the specifications of the rated voltage of the resection electrode.The cutting electrode bipo 21fr 46531313, batch # 21003482 was manufactured on 06/sep/2021.The batch consisted of 119 paks of electrodes.No issue was identified during production and no further complaints were received from the reported batch.The ifu ga-d 349 / en-us / 2015-02 v6.0 / eco 2014-0506 contains safety notes of avoiding excessive force in use of the device in section 7 use.The subject issue of breaking the device in use is present in the risk management file bb2 - not reusable electrodes, rev.: 03.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.

• Brand Name: E-LINE/PRINCESS
• Common Device Name: CUTTING ELECTRODE BIPO 21FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 22; 75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 22; 75438 knittlingen, germany ; GM
• Manufacturer Contact: oliver ehlrich ; pforzheimer strasse 22; 75438 knittlingen, germany ; GM
• MDR Report Key: 15463564
• Report Number: 9611102-2022-00047
• Device Sequence Number: 6873971
• Product Code: FAS
• UDI-Device Identifier: 04055207048962
• UDI-Public: 04055207048962
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: 46531313
• Device Catalogue Number: 46531313
• Device Lot Number: 21003482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 09/22/2022
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2021
• 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): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown