Model Number 011165-10 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/29/2022 |
Event Type
malfunction
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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.Internal karl storz reference number: (b)(4).
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Event Description
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The event occurred in canada.It was reported that the loop of the bipolar electrode broke off inside the patient during a transurethral resection of a bladder tumor but could be retrieved.No harm to the patient, the user or third reported.
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Manufacturer Narrative
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On 12/15/2022, ksec received inquiry from health canada requesting the additional information below: the investigation is still ongoing.We will provide you this information.1 similar complaint and or injuries reported with this device in canada in 2020 and 2 reported internationally in 2021.As the investigation is ongoing, the root cause can not be established.1/12/2023: investigation is being carried out by manufacturer kst.New anticipated date for the final report will be end of april.The event is filed under internal karl storz complaint id: (b)(4).
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Manufacturer Narrative
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Due to the heavy bending, it is assumed that the electrode got exposed to excessive force during the application.The force needed to create this bending is not required during application as intended.The event is filed under internal karl storz complaint id: (b)(4).
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Search Alerts/Recalls
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