MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK; CUTTING ELECTRODE MONO 24FR

Model Number	46782425
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User facility and manufacturer contacted for additional information.Upon receipt of information a follow-up report will be submitted.
Event or Problem Description
The user facility reported that dr.(b)(6) was doing a turbt and the loop that he was using broke in the specimen as he was cutting the tumor off of the bladder.The doctor was able to retrieve the broken piece and no harm was done to the patient.
Event or Problem Description
Follow-up report #1.Please refer to the manufacturer's narrative for details.
Additional Manufacturer Narrative
Follow-up report #1 is to provide fda with missing information, new information, and changed information.New information: h6, h10.Changed information: the following fields have changed information: b5, f7, g7, h10.The device was not returned and no further evaluation could be conducted; as a result, a probable root cause could not be determined.The following cautions, warning, and checks are outlined in the device instruction for use (ifu): caution: for parts being used in combination caution! do not combine products incorrectly! injuries of the patient, user or others as well as damage to the product are possible.The different products may only be used together if their intended uses and the relevant technical data (working length, diameter, peak voltage, etc.) are the same.Follow the instruction manuals of the products used in combination with this product.Follow the "notes and instructions on hf applications", order no.: ga-s 002 as well as the hf device manufacturer's instructions.Operating instructions include warnings about reusing or reprocessing a disposable device: if a disposable item is reprocessed, the product responsibility lies with the user or reprocessor.In this case the manufacturer can no longer guarantee the safety and performance of the product.Caution! about using to much strength the products have only limited strength! excessive force will cause damage, impair the function and therefore endanger the patient.Immediately before and after each use, check the products for damage, loose parts and completeness.Make sure that no missing parts remain in the patient.Do not use the products if they are damaged or incomplete or have loose parts.Additional notices include ensuring the electrode and resectoscope sheath are compatible.Cautions in the ifu about using the wrong irrigation fluid, the dangers of elevated temperatures when working without irrigation fluid, excessively high power settings.Rwmic considers this mdr closed.Follow-up reports will be sent to the fda if new information is received.Attachment: [ga-d366 usa_4.0 (16-0202).Pdf].

• Brand Name: SHARK
• Common Device Name: CUTTING ELECTRODE MONO 24FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10320831
• Report Number: 1418479-2020-00018
• Device Sequence Number: 515747
• Product Code: FAS
• UDI-Device Identifier: 04055207049044
• UDI-Public: 04055207049044
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020
• Report Date (Section F): 07/24/2020

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: No Information
• Device Model Number: 46782425
• Device Catalogue Number: 46782425
• Device Lot Number: 21002180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/05/2020
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/24/2020