Model Number 11301BNX |
Device Problem
No Display/Image (1183)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/11/2023 |
Event Type
malfunction
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Event Description
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It was reported that the device failed during use.Upon insertion into the patient's trachea, the image was lost on the c-mac monitor.Upon withdrawal, the image returned.But then the same failure occurred again.Or stuff needs to source an alternative scope to use.This added an extended period to the procedure, apparently turning a procedure that should have lasted approximately thirty minutes into one that lasted an hour and a half.No information about patient harm and the hazard so far.
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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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Manufacturer Narrative
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Investigation revealed that a piece of the membrane frame is broken off and the pressure dome main body shows missing pressure transmitting holes.According to the information received by legal manufacturer a wrong component was used to build the device during manufacturing process.The event is filed under internal karl storz complaint id: (b)(4).
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Manufacturer Narrative
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The complaint product was received on 2023-03-02 and was therefore available for investigation.Visual and microscopical examination revealed that shaft of the device was squeezed and the cover loosened from base near the distal tip.In addition a cut to the angulation cover, a leaky working channel and a vertebrae movement (deflection) was found.This will cause a image fail when activating the distraction.The device product history records have been checked for the available lot number no abnormalities were found.On the basis of the available information as well as the investigation results the error described by the customer can be confirmed.The root cause for the image failure during angulation of the video-endoscope is most likely due to a defective flexprint (loose contact).The defective flexprint which runs in the shaft is a consequential damage of the damages to the shaft.There is no indication for a material-, manufacturing- or design-related failure.The root cause of the reported issue can be traced back to a usage-related failure due to wrong handling.The event is filed under internal karl storz complaint id: (b)(4).
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Search Alerts/Recalls
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