MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK ELECTRODE; CUTTING ELECTRODE MONOPOLAR

Model Number	46782435
Medical Device Problem Code	Break (1069)
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.A follow up report will be submitted once additional information are available.
Event or Problem Description
On october 5th, 2020, the user facility contact rwmic and the following was reported: the loops were completely burning out and breaking during a turp- we went through 5 different loops in one case and it ended up charring the end of the sheath which led to bits of metal breaking off into the patients body.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? no.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) unknown.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.
Event or Problem Description
The purpose of this submission is to report the results of the device investigation.The device was received visually evaluated.The reported condition (loops burned) was confirmed.According to the manufacturer: "after consultation with the user it was determined that the electrodes were used with a medtronic generator.This caused the user to use 3-4 electrodes per turp.The generator was replaced and it was determined that the medtronic generator was causing the loops to burn out completely.According to the supplement bb-d366, system overview "shark" resectoscopes, the system components listed in the tables must only be used in compliance with the ga-d366 instructions for use.In general, the user is advised in the corresponding instructions for use ga-d366/en/2018-03 v5.0 pk 18-9297 under section 8 that a visual and functional check must be carried out before use.Do not use products that are damaged, incomplete or have loose parts.Possible damage or deviations can be easily detected by hospital personnel.".Probable root cause is thought to be user handling issue.The electrodes were scrapped.
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Follow-up report #1 is to provide fda with missing information, new information, and changed information.Missing information: user facility was contacted at least three times in an effort to collect patient information and user information.As of 07/26/2018, rwmic has not received a response from user facility.New information: the following fields have new information: b5, d10, g2 - 3, g6, h2 - 3, h6-7, h10.Please note the following mdrs are all tied together: 1418479-2020-00030 (rw complaint (b)(4) ).1418479-2020-00037 (rw complaint (b)(4) ).1418479-2020-00039 (rw complaint (b)(4) ).1418479-2020-00038 (rw complaint (b)(4) ).1418479-2020-00034 (rw complaint (b)(4) ).1418479-2020-00035 (rw complaint (b)(4) ).Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.

• Brand Name: SHARK ELECTRODE
• Common Device Name: CUTTING ELECTRODE MONOPOLAR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10728745
• Report Number: 1418479-2020-00035
• Device Sequence Number: 4086933
• Product Code: JOS
• UDI-Device Identifier: 04055207049051
• UDI-Public: 04055207049051
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

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: 02/28/2025
• Device Model Number: 46782435
• Device Catalogue Number: 46782435
• Device Lot Number: 21002253
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDSONIC GENERATOR
• Patient Sex: Unknown