|
Rwmic is submitting this report on behalf of richard wolf (b)(4).Richard wolf medical instruments corporation is the importer of this device.Warning! danger of burns! hf bipolar connection cables (14) with defective / brittle insulation can lead to burns.Danger for user and patient! broken electrical cables, no matter whether the insulation is damaged or not, can cause a light arc and thus may burn the user or patient, or start a fire.Do not use and do not repair a defective hf bipolar connection cable (14).Replace a defective cable.The connection cable (14) must not be modified under any circumstances.Use the hf bipolar connection cables (14) only at a maximum recurring peak voltage, up to 1000 vp.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: z bipolar application: 0.9% nacl solution (saline).Z monopolar application (only if required): 'no (saline) nacl solution.'the irrigation fluid must have a low conductivity (e.G.Glycine, purisole).Caution! danger of elevated temperatures when working without irrigation fluid! injuries to the mucous membrane due to excessive temperatures endanger the patient.Activate the electrode only while it is immersed in irrigation fluid and under continuous irrigation.To facilitate the evacuation of air bubbles generated mainly during bipolar tissue ablation (coagulation/vaporization), we recommend using sheaths with distally straight or oblique sheath ends.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! thermal damage may be caused if the vaporization electrode is permanently activated! high levels of heat or distal wear to the electrode insulation may be the result.When using the vaporization electrode, the following should be observed: no permanent activation of the vaporization electrode.Activation and pause phases should be implemented in the same way as when using a cutting electrode.'the vaporization electrode should only be activated when in contact with large areas of tissue.Excessive power settings can cause clearly increased electrode wear.We recommend starting at a lower power setting to determine the optimum power setting.Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.
|
|
This mdr is being submitted as part of a retrospective review of all 2016-2017 complaint files that rw mic is conducting.The complaint specialist determined a re-assessment of the mdr decision for this complaint was needed and that, this complaint, if a similar failure or malfunction were to occur with the same or similar device, could death, life threatening injury or life-threatening illness occur, an mdr should be filed.It was reported to richard wolf by the user facility that "electrode started burning out within first few seconds of being activated during a transurethral resection.Tried second electrode with the same result.Able to complete procedure with monopolar resection set." additional details: will the device be returned? yes (returned on (b)(4)).Was the device being used during a procedure when the issue occurred? yes.Specifically, was the device being used on a patient when the issue occurred? yes.Was there any injury or illness to patient or other personnel due to issue? no.Did the issue cause a delay in the procedure being performed that put the patient at risk? no.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.How was the patient anesthetized? unknown.Historical data: in the file from 2017, the following email is included: the original email from sales rep was received on 03/02/2017 at 12:39 pm.The sales rep, (b)(4), reports on tuesday (b)(6) at approximately 6:00 pm, the customer called me with complaint the bipolar urology resection equipment was not working correctly.The cable and post on working element are burnt, melted.Customer would like to know which was faulty and caused this.There was no injury to the patient or surgeon.I will send into wolf for inspection the following items: bipolar cutting electrode 22 fr 12/30(quantity 2).P/n: 4622.2533, s/n: (b)(4), product source: rwmic.Investigation report: physical findings: no findings.Complaint condition was not verified.Complaint is not valid; not burning out conclusion: no problem could possibly be from generator/power setting.Electrodes were testing using electrical means; hipot testor.Devices were scrapped, recommended they be replaced.Working element passive bipo 0/12/30.P/n: 8680.224, s/n: (b)(4), product source: (b)(4).Physical findings: burnt connector.Complaint condition verified.Yes, burnt connector.Conclusion: possible cable was damaged causing connector to get burnt.The part was repaired/cleaned and tested.Hf bipolar connecting cable l 3m.P/n: 8108.232, s/n: unknown, supplier: (b)(4).Physical findings: one of the connectors on the instrument end is melted complaint condition verified.No, unable to determine at this time.Conclusion: we are not able to test this cable.Cable not being sent back to the supplier ((b)(4)) "due to age of device, not being sent to supplier" the part was scrapped follow-up email from sales rep, (b)(4) (3/02/2017 1:27 pm), it is reported dr.(b)(6) was performing a transurethral resection of a bladder tumor.The electrode burn out within the first few seconds of activating.They then tried another electrode the same result.They then thought that perhaps the generator was faulty so they switched to a monopolar resection set and was able to complete the procedure.Trend analysis: 3/16/2017: no trends identified.Mdr decision history: on (b)(6) 2017, (b)(6), determined that this was non-reportable: no injury, to patient operating room staff.Backup device readily available for use.Minimal delay, minimal risk to patient.Procedure completed as scheduled.On (b)(6) 2020, (b)(6), determined that "if a similar failure or malfunction were to occur with the same or similar device, could death, life threatening injury or life-threatening illness occur?" yes an mdr should be filed.Recent communication i ((b)(6)) had with the marketing manager for urology: email to (b)(6) (1/12/2022 1:24 pm: "i need some help understanding what the surgeon might have done during a transurethral resection.I am writing a medical device report (mdr) for a complaint involving bipolar urology resection equipment (cutting electrodes bipo (46222533), a working element passive bipo (8680224) and a hf bipolar connecting cable (8108232)) and a erbe generator.The electrodes, started burning out within the first seconds of being activated so they switched to a monopolar resection set.When the surgeon switched to a monopolar resection set, does that mean, in your opinion - we have very little detail, that they changed out all the devices, the bipo electrodes, the working element and hf connecting cable?" his response (1/12/2022 1:33 pm): "based off of the bipolar instruments noted below, they would have to swap working elements, electrodes, and cables.You can use a bipolar working element and bipolar electrode with a monopolar cable, but that is considered off label use." follow-up question (1/12/2022 3:15 pm): "one last question: in your experience, is it more likely than not that it was the generator (excessive speed) that would have cause the electrode to burn? " his response (1/12/2022 3:32 pm): "most likely since we do not have our own hf generator." based on all the information available at this time, the mdr is being written against the electrodes since they burned.More likely than not the erbe generator, not returned/investigated by richard wolf, was the cause of the issue.
|
