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 08/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device was returned and evaluated at olympus (b)(4).Evaluation determined that the reported issue was confirmed.The unit probe was found fractured near the braze joint at the proximal end of the device.Damages found on the device are non -repairable.Reported failure likely attributed to user handling issue.
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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 therapeutic 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 review of the device history records (dhr).The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.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 ifu and as a preventive measure, the user manual states: 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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