Model Number SPL-PR340 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device was returned and evaluated at olympus malaysia service center site.Evaluation determined that the device shaft was broken.In addition, the spring was found broken and non-repairable.Both of the damages found on the device are non -repairable.Reported failure was confirmed.Likely attributed to users mishandling of the device.
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Event Description
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It was reported that the device probe was found broken due to hard and calcified stone.The issue occurred during a percutaneous nephrolithotomy (pcnl) procedure.No further details provided regarding the reported event.No patient impact or harm was reported.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the device return evaluation, complaint history review and investigation conclusion.Evaluation of the returned device confirmed the reported issue.The probe fractured approximately 6 inches from the proximal end.In addition, the spring was also broken.While a definitive root cause cannot be determined failure of this sort is often attributed to user technique.It is important the probe be held concentric to the instrument channel of the endoscope.Any applied torque may result in misalignment and contact wear leading to the fracture of the probe.As stated on the instructions for use as a preventive measure: the shockpulse-se should be placed in light contact with the stone.It is not necessary to press down on the stone with a lot of pressure.The probe is fragile.It is critical that the surgeon does not bend or torque the probes against the endoscope during the procedure.There is no need to rotate the probe or transducer; it will not improve fragmentation or stone clearance.Olympus will continue to monitor complaints for this device.
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Search Alerts/Recalls
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