Model Number 26331120-1 |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
Respiratory Acidosis (2482)
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Event Date 12/21/2021 |
Event Type
Injury
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Manufacturer Narrative
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According to a trend analysis, 2 similar complaints were found.In conclusion, the reported malfunction is no systemic issue.Further preliminary results are currently not available.After receiving the affected unit, an investigation will be performed by a designated karl storz employee.
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Event Description
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As per manufacturer incident report (b)(4) we received from the factory in (b)(6): during hysteroscopy-resection of a 4 cm type 2-3 fibroid, a desaturation in conjunction with a hypocapnia was reported.A further treatment was performed to exclude a gas embolism, but a pneumoperitoneum was found.A laparoscopy to eliminate uterine perforation or digestive wound.
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Manufacturer Narrative
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The device was evaluated on 2022-05-23.According to the visual inspection, only cosmetical damages could be found.Based on the log file analysis, the device was not started at the date of event.We conclude that the event occurred on 2022-04-12.No error message could be found.Upon next start up after 2022-04-12, the real time clock as well as the settings were reset, because the battery cell has come loose from its holder.This was probably caused by a mechanical shock.Based on the risk file, the most probable root cause is a user error, because the pressure was set to high.
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Manufacturer Narrative
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The device was evaluated on 2022-05-23.According to the visual inspection, only cosmetical damages could be found.No error message could be found.Upon next start up after 2022-04-12, the real time clock as well as the settings were reset, because the battery cell has come loose from its holder.This was probably caused by a mechanical shock.Based on the risk file, the most probable root cause is a user error, because the pressure was set too high.
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Search Alerts/Recalls
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