OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12-30, ESG TURIS
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Model Number WA22706S |
Device Problem
Material Disintegration (1177)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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As part of the investigation, olympus followed up with the user facility to obtain additional information.The referenced electrode was not returned for evaluation.Therefore, the root cause of the reported event cannot be determined.However, the investigation is ongoing.If additional information becomes available or if the device is returned at a later date, this report will be supplemented accordingly.
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Event Description
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The technical assistance center was informed that during procedure, the customer was experiencing that the loop at the distal end of the high frequency-resection electrode "plasmaloop", burned in half.No device fragment fell into the patient.No patient injury was reported.Occasionally, the doctors will need to pause during a procedure to wait for bubbles to go away so they can better visualize the area.The procedure was completed.
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Manufacturer Narrative
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The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The damage to the loop can most likely be attributed to wear and tear.The poor visibility can most likely be traced back to wrong handling.The bubbles described are gases that become visible in the conductive irrigation fluid (saline) and are produced by electrolysis during transurethral resection in saline and these are normal.The poor visibility of the surgical area is directly related to inadequate flow or the use of an inadequate flow rate, which could lead to delays in the operation and may also increase the temperature of the irrigation fluid.In addition, inadequate flow facilitates the accumulation of flammable gases, which may result in exogenous burns or other injuries if these gases are ignited by an activated electrode.It is therefore essential to extract the gases from the body in a controlled manner.It is recommended to take note of the information in the instructions for use and to check the fluid management for adequate flow of the irrigation fluid.Olympus will continue to monitor complaints for this device.
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