MAUDE Adverse Event Report: RICHARD WOLF GMBH S-LINE; WORKING ELEMENT ACTIVE BIPO 0/12/30°

Model Number 8680204

Device Problems Arcing of Electrodes (2289); Unintended Electrical Shock (4018)

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

Event Date 10/18/2022

Event Type  malfunction  

Manufacturer Narrative

The 8680204 working element active bipo 0/12/30° has been in the programme since 09/29/2006.The working elements from batch 1505196 were booked to the new goods warehouse on 04/04/2022 with a quantity of (b)(4) pieces.Of the (b)(4) pieces, (b)(4) pieces were shipped to our subsidiary in france.According to the production record, no indications of product or production defects are apparent.So far, no further complaint is known for the batch 1505196.The period 01/01/2019 to 10/18/2022 was subjected to a closer examination of the complaints database.(b)(4).The customer sent in his entire system for resection.This was subjected to a detailed examination.Apart from visible signs of ageing, no malfunctioning of the products could be detected.The electrical instruments were all intact and functional.A definite conclusion on the cause cannot be made due to missing information on power settings or the flushing fluid used.The "rtup" mode specified by the customer is not known for an erbe generator, which was used in this case, and does not allow any clear conclusions to be drawn about the actual parameters of the hf generator.In addition to an hf overshoot due to increased hf settings or the wrong choice of irrigation medium, the patient's startling can be caused by an irritation of the nervous obturatorius, which does not constitute an electric shock.However, these corresponding notes and warnings are all sufficiently described in the ifu ga-d342 / en-us / 2020-10 v9.0 / pk20-0319: 6.2.2.1 bipolar applications.Warning! danger of electric shock! do not connect the hf bipolar connection cable (14) to the monopolar socket of the hf surgical device.The hf bipolar connection cable (14) is only suitable for the bipolar socket of the hf surgical device.6.2.3 irrigation fluid.Caution! irrigation fluid can be electrically conductive! depending on the application the user must select a suitable irrigation fluid.Depending on the hf application, use the following irrigation fluids: bipolar application: 0.9% nacl solution (saline).Monopolar application (only if required): no (saline) nacl solution and the irrigation fluid must have a low conductivity (e.G.Glycine, purisole).6.2.4 hf applications.Warning! danger of injury if the hf instrument is not visible through the scope! inadvertent tissue damage as well as damage to the distal end of the endoscope and instrument parts are possible.Use hf instruments only within the scope of their specifications (voltage strength, duty factor).Activate the hf instruments only after the part conducting hf current has become fully visible through the scope and contact is made with the intended area to be treated.Caution! careful if hf output power is incorrectly selected! injuries to the patient as well as damage to the product are possible.The power should be set on the basis of the surgeon's experience and training with regard to the corresponding indication.Caution! careful if the hf voltage / power is set too high! danger of injury resulting from damage to the electrode insulation! damaged insulation can cause leakage currents.Thermal damage to the patient and / or user are possible.Replace electrode.Caution! danger of hf arcing! insufficient distance between parts conducting high-frequency current and other conductive parts as well as the extensive heat generated can result in unintended tissue damage and damage to the ceramic material on the sheath and on the endoscope.Activate parts of hf instruments conducting high-frequency current only when extended.In the case of hf arcing, replace the electrode immediately, check the endoscope for damage and send it in for repair if necessary to avoid consequential damage.Caution! danger of injury in the area of the sphincter/cervix! if the power setting is too high above the value recommended by the manufacturer there is the risk of increased thermal damage and abrasion as well as breakage of the electrode loop (wire).Increased irritation of the obturator nerve is also possible.The resultant convulsions may cause unwanted perforations.Set the power to the value recommended by the hf device manufacturer.Depending on the electrode power and mode, the depth effect (necrosis) is approx.0.5 to 2 mm.Make sure that in particular in the proximity of the sphincter and cervix you use the utmost care and the smallest possible hf power.A severe colour change to brown or carbonization of the tissue both indicate excessive power.In the risk assessment b6 reusable optical working inserts, rev.04, production-related, handling and design hazards with regard to a functional impairment as well as risks from a product that cannot be used were considered with the corresponding extent of damage and the assumed probability of occurrence and evaluated with an acceptable risk.Since no new risks have arisen from the investigation of the current complaint case, the risk assessment remains valid in view of the facts described.As a conclusion, the correct selection of power settings and an appropriate handling during hf application are an essential point in the use of electrodes.But, as no further information are available, a final assessment cannot be made.Rwgmbh will submit a follow-up report if new information becomes available.

Event Description

Richard wolf gmbh reference: (b)(4).Richard wolf gmbh in (b)(4) (manufacturer) was informed about the following: description of incident/claim according to the customer: "on (b)(6) 2022 scheduled intervention: endoscopic resection of the prostate.All connections were correct, the right mode/program "bipolar rtup".The surgeon induces the resector, starts the "sectioning" of the prostate and the patient on jumps like an external shock or electrostimulation.Alerting the regulator and the executive who came directly.Moreover it is the second undesirable event in the same room, on the same intervention that occurred on (b)(6) 2022.Yesterday the intercom was triggered several times just before the arc and today we notice the general lighting of the room that flashes in an unsystematic way." the user informed that there were no negative consequences for the patient, user or third parties.The user stated to report it to ansm.Rwgmbh mdr awareness date: (b)(6) 2022.

• Brand Name: S-LINE
• Type of Device: WORKING ELEMENT ACTIVE BIPO 0/12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; 75438, knittlingen, germany ; GM
• Manufacturer Contact: philipp schmidt ; pforzheimer strasse 32; 75438 knittlingen, germany ; GM
• MDR Report Key: 16009294
• MDR Text Key: 308537386
• Report Number: 9611102-2022-00061
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2022

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
• Device Operator: Other
• Device Model Number: 8680204
• Device Catalogue Number: 8680.204
• Device Lot Number: 1505196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1