MAUDE Adverse Event Report: RICHARD WOLF GMBH PRINCESS; WORKING ELEMENT ACTIVE MONO/BIPO

Model Number	8653204
Medical Device Problem Codes	Ambient Noise Problem (2877); Excessive Heating (4030)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The working element active mono/bipo: part no.8653204, lot no.1378013, was manufactured on 09/apr/2018.According to the production record, no abnormalities have been noted.As soon as the investigations are completed, a follow-up report will be submitted.
Additional Manufacturer Narrative
The entire system, apart from the used electrode(s), was returned for investigation.They were investigated in the responsible department.It was determined that the system has no defects according to the test instructions.The insulation and continuity tests are in compliance.The instruments only shows typical signs of use.However, the error pattern of a noise and a burn indicates an electrical arcing together with a burn-through of the cable and/or the electrode.As a result, the replacement of the cable/electrode is necessary, which was also described by the user as remedial action.However, a defective cable or electrode was not returned by the user.Furthermore, no settings of the hf generator were indicated, which is usually the cause of the error pattern.The working element active mono/bipo 865320, batch # 1378013 was manufactured on 09/apr/2018.The batch consisted of 5 pieces.No issues were identified during production, no further complaints were received from the reported batch.The ifu ga-d 349 / en-us / 2015-02 v6.0 / eco 2014-0506 contains several descriptions regarding the proper handling and correct settings during hf application in sections 8 checks, 7.1.7 inserting working insert (7) with panoview telescope (8) into the resectoscope sheath, 7.1.10 inserting working element (9) (10) into the resectoscope sheath, 7.2.4 irrigation fluid and in section 7.2.5 hf-application (monopolar/bipolar).The subject issue of noise and burn of the devices is present in the risk management file b6 - reusable optical working inserts, rev.04.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: PRINCESS
• Common Device Name: WORKING ELEMENT ACTIVE MONO/BIPO
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 2; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• Manufacturer Contact: philipp schmidt ; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• MDR Report Key: 16366924
• Report Number: 9611102-2023-00010
• Device Sequence Number: 7544094
• Product Code: FDC
• UDI-Device Identifier: 04055207018613
• UDI-Public: 04055207018613
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2023

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?: No
• Operator of Device: Other
• Device Model Number: 8653204
• Device Catalogue Number: 8653204
• Device Lot Number: 1378013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown