The affected products were received by the manufacturing site in germany on (b)(6) 2022 for investigation.During the evaluation it was determined that the optic sent in by the customer is a third party product.The article 27040e/working element is a karl storz product but has also a third-party inscription on the shaft, which proves that the article was repaired by a third party.Two of the electrodes are bent, which indicates that force was applied without activating.All other devices which were sent in by the customer showed no defects apart from normal signs of use.Under certain circumstances, a combination of a foreign optics and a foreign repair can promote damage or improper functioning of the instruments.No indication for a material or manufacturing related issue was found during the investigation.The detected error concerns only the electrode (27040g); therefore, the device in this supplement report has been changed to the 27040g electrode.Following is a list of accessories used for the case: 27040xa - inner sheath - karl storz.26040sl - resectoscope shaft, 26 charr.- karl storz.27040e - working element - karl storz.27040g - cutting snare, angled, 24 charr.- karl storz.27040vg - spike electrode, 24 charr.- karl storz.27040n - coagulation electrode, 24 charr.- karl storz.27040l - coagulation electrode, 24 charr.- karl storz.27068k - knife, straight - karl storz.27040oc - standard obturator - karl storz.27021o - filling rod for 27026e/ef/eg/eh - karl storz.26163v - examination shaft, ø 5.1 mm - karl storz.279 - unipolar high-frequency cable, 300 cm - karl storz.495na - fiberoptic light cable 230cm/ø 3.5mm - karl storz.Hf sclapel embe - batch #112-83-884 //.Hf scalpel erbe - batch #112-83-884.Ak - optic.
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