Model Number CW-RBPBX |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.
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Event Description
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It was reported that during a pnl (percutaneous nephrolithotomy) procedure, the device broke off.According to the reporter, the device fell apart in the user hand.The intended procedure however was completed with no patient harm or impact due to the event.No user harm or injury reported.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the investigation conclusion of the reported issue.The device has not been made available to olympus market quality for evaluation.For this reason, the reported failure could not be confirmed and a definitive root cause could not be determined.Dhr review cannot be completed as the device lot number is unknown.Similar failures have occurred as a result of user mishandling.The probe is fragile and may fracture if excessive pressure and/or torque are applied.The probe must be kept concentric to the endoscope's instrument channel while active to prevent the introduction of unnecessary torque on the probe.Per the device ifu (instruction for use), states, "the probe sets are fragile.It is critical that the surgeon does not bend or torque the probes against the nephroscope during the procedure.There is no need to rotate the probe set or transducer; it will not improve fragmentation or stone clearance." olympus will continue to monitor complaints for this device.
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Event Description
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The reported the event occurred during a percutaneous nephrolithotomy therapeutic procedure.No other devices were involved in the event.There was no delay and the procedure was completed with a second device.There was no patient injury/harm.Patient demographics: the break occurred outside of the patient.The lot number of the subject device remained unknown.
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Search Alerts/Recalls
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