Model Number 26331120-1 |
Device Problem
Ambient Noise Problem (2877)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/04/2022 |
Event Type
Injury
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Event Description
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As per manufacturer incident report # (b)(4) we received from the factory in germany: during procedure, the endomat emitted an important noise that led the operators to turn it off as a precautionary measure.The device was replaced with a system consisting of a bag press and a vacuum cable to be connected directly to the vacuum of the operating room.According to the customer's information, the non-use of the endomat caused a "considerable lengthening" of surgical time.
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Manufacturer Narrative
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The affected device was requested for return.The investigation is pending.After receiving the affected unit, an investigation on the returned product will be performed by a designated karl storz employee.
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Manufacturer Narrative
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The claimed item was returned on 2022-08-01.Based on the evaluation results (dated 2022-09-08), the device is able to work as per factory specifications.A test for 12 hours with the maximal flow could not provoke the reported noise.Based on the log file analysis, the failure could not be traced back to a setting error nor a human error.In conclusion, the reported malfunction could not be confirmed.
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Search Alerts/Recalls
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