MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK; CUTTING ELECTRODE MONO 24FR, STERILE, FOR SINGLE USE

Model Number	46782425
Medical Device Problem Codes	Material Rupture (1546); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf (b)(4).Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr/complaint open.Rwmic will submit a follow up report after the device evaluation has been completed and/or new information becomes available.Rwmic will reach out to user facility to request additional information.
Event or Problem Description
On november 12th, 2020, the user facility reported the following to richard wolf medical instruments corporation (rwmic): dr.(b)(6) had 4 monopolar electrodes that literally blew up in a turp case.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? unknown.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? yes.Did the delay put the patient at risk? (only applicable if there was a report of delay) yes was there a similar back-up device available for use? yes.Was the scheduled procedure completed? no.
Additional Manufacturer Narrative
Follow-up report #1 is to provide fda with missing information, new information, and changed information.Missing information: the user facility was contacted three times in an effort to collect patient and other missing information.On march 30, 2021 we received a response that no further information is available.Results of the device investigation: the device was visually and functionally evaluated and found to have a manufacturing defect which was caused by rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr closed however should we receive additional information a follow-up report will be submitted.
Event or Problem Description
For results of the device investigation see the manufacturers narrative.

• Brand Name: SHARK
• Common Device Name: CUTTING ELECTRODE MONO 24FR, STERILE, FOR SINGLE USE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 11020631
• Report Number: 1418479-2020-00048
• Device Sequence Number: 3823280
• Product Code: JOS
• UDI-Device Identifier: 04055207049044
• UDI-Public: 04055207049044
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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 Expiration Date: 12/31/2024
• Device Model Number: 46782425
• Device Catalogue Number: 46782425
• Device Lot Number: 21002048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1