MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK; CUTTING ELECTRODE MONO, STERILE

Model Number	46782425
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
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.
Event or Problem Description
The following was reported to rwmic on (b)(6) 2021: during a procedure the electrodes were shredding and breaking off.Electrode loop breaking left from right.Three broke and was able to finish case with fourth electrode used.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) no.Was there a similar back-up device available for use? n/a.Was the scheduled procedure completed? yes.
Event or Problem Description
Additional details received by richard wolf about the devices used: according to the sales rep, the settings used: power settings 80/80.That means 80 cut and 80 coag.Picture of the generator used during the procedure is attached and forwarded to rw gmbh for the device investigation.Investigation report: device evaluation from rw gmbh.The device was sent to rw gmbh for evaluation.Findings: "the devices were inspected in the responsible department.The received information about the used hf generator and the power settings without the information about the duration of the procedure and the used product combination is not sufficient enough to determinate the cause of the event further.Three electrodes 46782425 cutting electrodes mono 24fr 12/30 were received.All electrodes show damage to the distal insolation and two electrodes broke at the loop.In addition, all electrodes are severely bent and in two electrodes the reinforcing tube is displaced.The visible changes on the electrodes indicate mechanical and thermal-electrical overloads.However no definitive statement can be concluded based on the available information to what exactly caused this overload.The further deformations of the electrodes and the forward displaced reinforcing tube could have been caused by applying too much force during assembly or disassembly of the electrodes.As a result, the isolation may have been pre-damaged and further damaged during the use with hf current.Therefore, the user is advised in the relevant ifu ga-d366-usa rev.04 to carry out visual checks and to avoid strong use of force on the electrodes.In addition, the assembly and disassembly procedure is also described in details." the reported condition was confirmed.Probable root cause: user error.

• Brand Name: SHARK
• Common Device Name: CUTTING ELECTRODE MONO, STERILE
• 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: 11378672
• Report Number: 1418479-2021-00005
• Device Sequence Number: 3712486
• Product Code: FAS
• UDI-Device Identifier: 04055207049044
• UDI-Public: 04055207049044
• Combination Product (Y/N): N
• 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: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

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: 01/31/2025
• Device Model Number: 46782425
• Device Catalogue Number: 46782425
• Device Lot Number: 21002180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: COVIDIEN VALLEYLAB FT10.FT SERIES ENERGY PLATFORM.; GENERATOR INFO ONLYASKED FOR BUT NOT GIVEN ALL.
• Patient Sex: Unknown