This scope was not received for investigation at stryker endoscopy because it was investigated by the legal manufacturer, (b)(4).Alleged problem(s): damage to working channel alleged problem confirmed: yes according to (b)(4): visual inspection: scope was evaluated by eye, with eye loupe and microscope to determine that the scope has a cracked needle weld.Functional inspection: scope was evaluated by eye, with eye loupe and camera system to determine that the image is dark and hazy due to the cracked needle weld.Probable root cause: thermal destruction of epoxy, improper/third party repair , improper epoxy/curing process, laser welding failure, use error, contact with instrument.The product was returned to (b)(4) for investigation and the failure mode will be monitored for future reoccurrence.(b)(4).
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