MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK/S-LINE; CUTTING ELECTRODE BIPO 26FR 12/30°

Model Number 4624.1313

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2022

Event Type  malfunction  

Manufacturer Narrative

Rwmic is submitting this report behalf of the manufacturer richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.The device was requested from the user facility.Rw gmbh considers this mdr open.A follow-up report will be submitted after the device evaluation has been completed and/or new information becomes available.

Event Description

On july 20, 2022 richard wolf gmbh was informed by rw uk about an adverse event.Richard wolf gmbh complaint reference: (b)(4).Patient a was attending urology theatre for the following procedure: cystoscopy, bladder biopsies, re-do green light laser prostatectomy (gllp) and trans-urethral resection of prostate (turp).Whilst using the wolf bipolar handpiece with cutting electrode attachment (loop) for the turp, the metal wire of the loop broke away at one side.This loop was immediately removed by surgeon a who requested another which nurse a provided to replace the damaged electrode.However, this loop then broke away entirely from the tip into the bladder when surgeon a resumed the procedure.The procedure then had to be completed using monopolar diathermy.Rwgmbh awareness date, 20-july-2022.

Manufacturer Narrative

Follow-up report #1 is to provide fda with device evaluation results.New information: b4, b5, d9, g4, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), and h10.The user sent both electrodes for investigation.The electrodes were checked in the responsible department.The two electrodes showed different signs of damage.On one electrode there was a loss of parts as described by the user.On the second electrode, the wire clip burnt through on one side.There was no loss of parts on this electrode.On the one hand, excessive force applied by the user could have caused a purely mechanical failure of the wire clip.On the other hand, the damage could have been caused by ageing.Also, damage caused by the use of hf current.When using hf current, there are system-related signs of ageing on the application part (in this case the wire bow).This wear depends on many factors such as the type of hf generator, the setting of the hf generator, tissue contact, cutting speed, etc.Excessive power settings on the hf generator can lead to rapid wear even within one application, which eventually leads to breakage of the applied part.The user is therefore advised in the instructions for use to keep the power setting low.There are also instructions warning the user not to exert too much force with the electrode.Corresponding risks are listed and evaluated in the risk assessment bb2-3.Within the scope of the product design, appropriate measures were taken to prevent mechanical overstressing and to reduce and to minimize the effects of ageing due to thermal influences and hf-current during use in accordance with the intended purpose.A final evaluation cannot be made because the settings of the hf generator were not made available.In addition, no information was provided about the duration of use and the devices used in combination.The ga-d342 instructions for use applicable to this system refer to the points outlined above with different warnings: 5 combinations warning danger if the products are incorrectly combined! injuries of the patient, user or others as well as damage to the product are possible.Different products should only be used in combination if their intended uses and relevant technical data (working length, diameter, peak voltage, etc.) are the same.Follow the instructions for use of the products used in combination with this product.Follow the "notes and instructions on hf applications", order no.:ga-s002 as well as the hf device manufacturer's instructions.7 use the products have only limited strength! exerting excessive force will cause damage, impair the function, and therefore endanger the patient.Caution the products have only limited strength! exerting 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.7.2.4 hf application warning there is a risk of injury if the hf instrument is not in the operator's field of vision! unintentional tissue damage, as well as damage to the distal end of the endoscope, and to the instrument parts is possible.Use hf instruments within the given specifications (dielectric strength,operating mode).Do not activate hf instruments until the hf current-carrying part appears fully in the field of view of the endoscope and the intended application area is contacted.Warning excessive hf voltage! exceeding the maximum recurring peak voltage of the hf instrument in combination with hf surgical devices and/or the incorrect selection of the operating mode can destroy the insulation and lead to leakage currents.Thermal tissue damage to the patient, user, and others is possible.Warning incorrect selection of the hf output power! injuries to the patient, as well as damage to the product are possible.The power setting must be adjusted in accordance with the operator's experience / training with reference to the applicable indication.8 checkswarning injuries due to damaged or incomplete products! injuries to the patient, user, and others are possible.Do not use the products if they are damaged and incomplete or have loose parts.Run through the checks before and after each use.8.1 visual checks check products and accessories for: damage sharp edges loose or missing parts raw surfaces pay special attention to the insulation.8.1.4 electrodes 1.Check the insulation.Replace the electrode in the event of: damaged insulation distal wear of the insulation 2.Disposable electrodes,sterile check the sterile packaging.The bipo 26ch12/30° cutting electrode has been in the programme since 07.04.2009.The lot 4500355572 consists of 100 pak.1 pak = 3 pieces.99 pak of the cutting electrode bipo 26ch 12/30° from the lot 4500355572 were sold in the period 04.27.2022 to 06.15.2022.1 pak was stored as a reserve sample.1 pak from lot 4500355572 was delivered to rw uk on 03/06/2022.As of 19/08/2022, no further electrodes from lot 4500355572 have been complained.Possible hazards were considered in the risk assessment bb2-3 rev.05 (non-reusable resection electrode) with the corresponding extent of damage and probability of occurrence.In summary, the information provided by the user and the research do not indicate a product or manufacturing defect in lot 4500355572.A mechanical or electrical overload is assumed.To counteract this, the user is informed in the relevant instructions for use about the checks to be carried out before and after each use.- use hf instruments within the given specifications (dielectric strength, operating mode).- do not activate hf instruments until the hf current-carrying part is fully in the field of view of the endoscope and the intended area of application is contacted.In addition, he/she is advised not to use any damaged products.In our opinion, the damage could have been detected at an early stage and the appropriate action taken if the instructions for use had been followed.Based on the above findings, no further action is considered necessary.Rwgmbh considers this matter closed.Rwmic is submitting this report on behalf of the manufacturer rw gmbh.

Event Description

Richard wolf gmbh complaint reference qm(b)(4).The purpose of this submission is to report the results of the device investigation: (see h10).Rwgmbh device investigation awareness date, 26-oct-2022.

• Brand Name: SHARK/S-LINE
• Type of Device: CUTTING ELECTRODE BIPO 26FR 12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; 75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer Contact: oliver ehgrlich ; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• MDR Report Key: 15260992
• MDR Text Key: 305423016
• Report Number: 9611102-2022-00040
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207048924
• UDI-Public: 04055207048924
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 4624.1313
• Device Catalogue Number: 4624.1313
• Device Lot Number: 4500355572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention