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Rwmic is submitting this report on behalf of (b)(6) gmbh.(b)(6) medical instruments corporation is the importer of this device.Because the device was not returned, (b)(6) gmbh reviewed the product history.According to (b)(6) gmbh, "within the last 3 years (b)(6) received only one complaint with this product.The complaint was from a (b)(6) customer and was received in july 2019.The investigation showed that the electrode head was loosen because of broken wires on the distal end.In addition the distal head was strongly discolored and showed strongly of thermal wear.Further discoloration could be seen on the guide tubes.According to our experience, excessive power settings on the hf generator can lead to rapid wear and tear which leads to breakages of distal parts.To avoid such damages during application the user is advised in the instruction manual ga-d342 that thermal damages may be caused if the vaporization electrode is permanently activated and that because of an incorrectly selected hf output power damages of the product are possible.No further action is required." the user is informed in the ifu ga-d342 about the following safety notices and instructions regarding the reported issue that the product caused: 6.2.2.2 monopolar application: important! if necessary, the s(a)lineresectoscopes can also be used for monopolar hf applications, e.G.To complete an operation.Only cutting, hook or coagulation electrodes should be used for this application.The use of vaporization electrodes is not recommended.Section 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 be¿come fully visible through the scope and contact is made with the intended area to be treated.Warning! danger of explosion if the electrode is activated in an air or gas bubble (e.G.Near the top of the bladder)! this may cause injuries to the bladder or uterus wall.Activate hf current only if: the electrode is visible through the scope and is fully immersed in the irriga.¿ the desired tissue contact is made.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 endo¿scope.Activate parts of hf instruments conducting high-frequency current only when extended (fig.23).In the case of hf arcing, replace the electrode immediately, check the endo¿scope for damage and send it in for repair if necessary to avoid consequential damage.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 note: excessive power settings can cause clearly increased electrode wear.We recom¿mend starting at a lower power setting to determine the optimum power setting.In the risk assessment, the possible risks due to failure of the corresponding extent of damage and the assumed probability of occurrence were considered and assessed as an acceptable risk.Rwmic considers this mdr/complaint open.Rwmic will submit a follow up report after contacting the user facility for additional information and/or new information becomes available.
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It was reported by the user facility to richard wolf that "after 40 minutes of use, the insulation melted, one of the prongs broke, and the instrument became encrusted with a black charred material." the item was discarded at the facility.Additionally: will the device be returned? no.Was the device being used on a patient when the reporting 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? no.Did the delay put the patient at risk? n/a.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.
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Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Three attempts were made to collect missing information from the user facility through the sales rep as of (b)(6) 2021 rwmic has not received any new information.Rwmic considers this case closed.A follow up report will be submitted if and when new information is received.New information was added to the following: g2, g6, h2, h10.
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