The product 27040db was returned to the manufacturer for investigation, while the 011160-10 was discarded by the end user.The investigation was completed on october 13, 2023.The analysis of 27040db revealed the presence of corrosion traces on the entire surface, particularly around the catch for the sling, as well as deformation at the distal end of the shaft.Similar cases involving the 011160-10 indicated that the cutting electrode was subjected to excessive force during application, and it is likely that this was the case here as well.For the 27040db, it was determined that the working element had been incorrectly reprocessed, leading to corrosion throughout the article and deformation at the distal end, both of which resulted from use mechanical damage.The instructions for use (ifu) 97000160 v10.3/01/2019 already contain a caution regarding not overloading the device.It is concluded that the event did not and might not lead to death or serious deterioration in the state of health.No serious public health threat reported.No death or unanticipated serious deterioration in state of health reported.Consequently, the reported issue does not fulfil the criteria of a serious incident ,therefore this case is not reportable.Internal karl storz reference number: (b)(4).
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