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

Model Number	8653224
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility has informed richard wolf gmbh an issue regarding working element passive mono/bipo, part no.8653224 with lot no.1506016.According to the received information: "during the resection, 10 minutes after the beginning, we heard a thud: there was a flame and it remained incandescent for 1 minute.The bipolar cable caught fire at the base of the connection (resection handle side)." the treatment was continued with other products and completed with an unspecified delay.The user informed richard wolf gmbh that there were no negative consequences for the patient, user or third parties.
Additional Manufacturer Narrative
New information: b4, d10, g1 (contact), g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h7, and h10.The user has returned the entire system, except the used electrode(s) for investigation.It was determined that the reported device working element passive mono/bipo 8653224, the returned working element active mono/bipo 8653204, the returned obturator resectoscope 865318 and the returned outer sheath resectoscope 21fr 8653021 have no defects according to the test instructions.The insulation and continuity tests are in compliance.The devices only show typical signs of use.The returned fiber light cable bndl could only be examined visually due to damage.The fiber light cable is broken and burned through at the base of the connection (resection handle side).It could not be ruled out that the fiber cable was not damage prior to the procedure which may cause the reported error of flame.However, the inside of the insulation of the returned inner sheath resectoscope 19fr 8653018 is damaged.Also there is dirt inside the returned telescope 12° ø 2,7mm sl 310mm 8974.412, although this does not influence the functionality of the optic.The reported error pattern of noise and flame indicate an electrical arcing together with a burn-through of the cable and/or electrode.Also the damage inside the insulation of the returned inner sheath resectoscope 19fr 8653018 indicates an activation of the electrode inside the device instead of under control of the user's view.The working element passive mono/bipo 8653224, batch # 1506016.The batch consisted of 20 pieces.No issue was identified during production, no further complaints were received from the reported batch.The ifu ga-d349 / 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 PASSIVE MONO/BIPO
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: zsófia bartholome-nagy ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 16559233
• Report Number: 9611102-2023-00017
• Device Sequence Number: 14866350
• Product Code: FDC
• UDI-Device Identifier: 04055207042908
• UDI-Public: 04055207042908
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8653224
• Device Catalogue Number: 8653.224
• Device Lot Number: 1506016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INNER SHEATH RESECTOSCOPE 19FR 8653018; OBTURATOR RESECTOSCOPE 865318; OUTER SHEATH RESCETOSCOPE 21FR 8653021; TELESCOPE 12° Ø 2,7MM SL 310MM 8974.412; WORKING ELEMENT ACTIVE MONO/BIPO 8653204
• Patient Sex: Unknown