KARL STORZ SE & CO. KG ELECTRODE, BIPOLAR; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLSR, SINGLE USE
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Model Number 011050-10 |
Device Problems
Component Missing (2306); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that during use after 10 minutes, the loop detached from the side poles to which it is attached.Possible fragments not recovered.No harm to patient, user or third reported.
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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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The product was returned on 2024-03-04.The investigation of the product was completed on 2024-03-20.The device product history records (dhr) have been checked for the available lot number and found to be according to the specification, valid at the time of production.The problem described by the customer can be confirmed.The working electrode is molten down completely - the neutral electrode is partially molten.There is no indication for a material-, manufacturing- or design-related failure.Most likely, the damage has been caused by excessive force applied to the cutting loop during application, led to a break of the cutting electrode and by touching the neutral electrode creating a shortcut which, in the end, melts the electrodes.The root cause of the reported issue can most likely be traced back to a usage-related failure.The event is filed under internal karl storz complaint id: (b)(4).
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Search Alerts/Recalls
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