Model Number UP210 |
Device Problem
Pumping Stopped (1503)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/12/2023 |
Event Type
Injury
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Manufacturer Narrative
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The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
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Event Description
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The event occurred in (b)(6).It was reported that the stopcock on the sheath leaked during use and the pump stopped working during surgery.There was a prolongation of 1 hour and they had to convert to a mini-laparotomy (open surgery) to remove the prostate.
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Manufacturer Narrative
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Additional information is provided in section d9 to reflect that the product was returned for evaluation.The item in question was returned to the manufacturer.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
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Manufacturer Narrative
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The stopcock on the sheath leaked during use and the pump stopped working during surgery.During product inspection of the returned products (one-pedal-footswitch and endomat select) no issue could be reproduced during testing.It is also concluded that the unreturned tubing set is not the cause of the reported error.However, the event log of the endomat select shows issues with the pressure (pressure deviations and high pressure) and afterwards issues with the pressure sensor offset calibration on the date of the incident.The affected endomat select was manufactured on 20.02.2019.It was in repair once in 2019 due to defective light guides.This has no influence on the reported problem.Due to the event log entries found, the most probable root cause is an issue with a defective pressure sensor membrane.This would lead to the logged events of very high pressure differences.It could also be possible that water entered the device and shorted some connections on the pressure sensor board, which then could have lead to the issues with the pressure offset adjustment.This is not visible.Based on the given facts we set the root cause to wearing.The event is filed under internal karl storz complaint id: (b)(4).File attachments: no files.
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Search Alerts/Recalls
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