The device will not be returned to olympus for analysis as it was disposed of after the case.H4: the exact manufacture date could not be identified without the return of the device for analysis, however based on the lot number provided, it was determined to be manufactured in june 2021.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.This report has been submitted by the importer under this mdr report number 2429304-2023-00266.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the prolonged procedure and anesthesia time occurred due to the device malfunction.However, the root cause could not be specified.Additionally, based on the results of the investigation and investigation results in the past, due to various factors such as the size, hardness or shape of the calculus, a load beyond the resistance strength might have applied to the product during the lithotripsy.As a result, the basket wire was possibly broken.However, the device was not returned and the root cause of the device malfunction could not be determined.The event can be detected/prevented by following the instructions for use which state: do not use this instrument for a calculus that is assumed impossible to be crushed by a lithotriptor.The pipe or the basket wire may break and part of this instrument may remain in the body.Use this instrument by having the settings to switch to open surgery and the hospitalization plan ready in case the calculus cannot be crushed by lithotriptor bml-110a-1.A lithotriptor cannot always crush all calculi captured in the basket.Operation of this instrument is based on the assumption that open surgery is possible as an emergency measure.If the calculus is too hard, it is possible that the damages shown in chapter 5, ¿emergency treatment¿ may occur.Use the lithotriptor by considering that it may lead to damaging the instrument and that open surgery may have to take place.This instrument will deform and/or deteriorate by performing lithotripsy.When lithotripsy is repeated, it will deform and/or deteriorate furthermore.By such deformation and/or deterioration, calculus may not be crushed and/or the instrument with calculus engaged may not be removed from the body.If lithotripsy is required to be repeated in a single case, make sure to check each time that no abnormality is found in action and/or appearance (e.G.Basket wire cut or worn, tube sheath bent, notable coil sheath bent or gap etc.).Stop use when any abnormality is detected.During lithotripsy, keep the portion from the coil sheath to the bml handle straight in line with the scope¿s biopsy valve, as much as possible.If not straight, the coil sheath may bend, calculus may not be crushed, and/or the instrument with calculus engaged may not be removed from the body.Do not rotate the bml handle knob abruptly.This instrument may break, and/or calculus may not be crushed.Also, the instrument with calculus engaged may not be removed from the body.Olympus will continue to monitor field performance for this device.
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When the original device was connected, no pressure was being applied to the stone and the handle retracted all the way out and then continued spinning.The handle was reattached with the same result leading the device to fail, therefore the rescue device was applied.Tension and pressure were applied in attempt to crush the stone, however the wire broke inside the rescue handle.The sheath surrounding the wire was then cut to modify the device and give more wire to wrap in the rescue handle.The emergency handle was able to start turning the wires and the stone was then crushed.
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