Model Number 27040GP1 |
Device Problems
Loss of or Failure to Bond (1068); Fracture (1260); Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/08/2023 |
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.The event is filed under internal karl storz complaint id: (b)(4).
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Event Description
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It reported that a new loop was used for the surgical procedure and in the middle of the endoscopic bladder surgery, a part of the loop was broken; this part of the loop is seen by the camera in the video tower.
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Manufacturer Narrative
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Additional information is provided in section.The device is not available to be returned to manufacturer.The event is filed under internal karl storz complaint id: (b)(4).
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Event Description
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A new handle was used for surgical procedures and in between endoscopic bladder surgery.Evidence of rupture of a part of the loop; this part of the handle is seen by the camera in the video tower.There were no adverse consequences to patient user or third due to this incident, no surgical delay, and no additional intervention was necessary.
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Manufacturer Narrative
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The complaint product was not available for investigation.The complaint sample has been requested at least 3 times.A investigation of the complaint device itself was not possible, but pictures were provided by customer.Based on these pictures, the customer's description and the similar complaints, it can be assumed that this damage was caused by overloading the item.This damage may have been caused by too much force or too long a peak voltage.The event is filed under internal karl storz complaint id: (b)(4).
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Search Alerts/Recalls
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