MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK/S-LINE; CUTTING ELECTRODE MONO 24FR 12/30°

Model Number	8622131
Medical Device Problem Codes	Material Fragmentation (1261); Excessive Heating (4030)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility has informed richard wolf gmbh an issue regarding a cutting electrode bipo 24fr 12/30°, part id: 8622131, lot # 21003950.According to the received information, during procedure the loop has broken inside the bladder and the loop was burnt.
Additional Manufacturer Narrative
This case was reported by the customer to the french national agency for the safety of medicines and health products (ansm), known as "agence nationale de sécurité du médicament et des produits de santé".Rwgmbh has received the new event notification from the customer on (b)(6) 2023.The instrument has not yet been sent for examination by the user.A follow-up report will be submitted when device evaluation has been completed.
Additional Manufacturer Narrative
The damage to the electrode indicates a high heat effect of the hf current between the electrode loop and the guide tube.Possible explanations for this heat effect is a short circuit between electrode loop and guide tube.Further activation results in high current densities and thus heat generation, which can lead to melting of metals.The present cutting electrodes bipo 24fr 12/30° part id: 8622131 originate from batch # 21003950.This batch was added to the neuwar-enlager on (b)(6) 2022 by our supplier, (b)(4).The supplier (b)(4) confirms in the chain of custody the inspection and compliance with the specification of this type and batch.The delivery to the customer took place on (b)(6) 2022.In summary, the information provided by the customer and the damage pattern suggest that improper handling has occurred (user error).To counteract this, the user is informed in the associated instructions for use about the checks to be carried out before and after each application.In addition, the user is advised not to use any to stop using any damaged products.The short-circuit could have been avoided by following these instructions in the instructions for use.The electrodes are subjected to a 100% electric breakdown test during production.A production-related defect can thus be largely excluded.Possible damage can be caused by reprocessing and ageing, and lack of visual inspection after reprocessing or before use can lead to the use of a defective product.Notes on this are listed in the instructions for use.Possible hazards due to thermal energy were considered in the risk assessment b2-3, rev.04 with the corresponding extent of damage and probability of occurrence.This assessment remains valid taking into account the new case.

• Brand Name: SHARK/S-LINE
• Common Device Name: CUTTING ELECTRODE MONO 24FR 12/30°
• 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: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 17162657
• Report Number: 9611102-2023-00036
• Device Sequence Number: 5590369
• Product Code: FAS
• UDI-Device Identifier: 04055207018019
• UDI-Public: 04055207018019
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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
• Device Model Number: 8622131
• Device Catalogue Number: 8622131
• Device Lot Number: 21003950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown