The device was evaluated by the manufacturer, karl storz in (b)(4).Per their evaluation, "the bayonett deformed and the insulation of the sheath damaged (cuts and scratches) all over the length.The deformation of the bayonett pre-damaged the bayonett wing and lead to the final break.The damages in the insulation would have been justification enough to take this part out of service long ago, as the insulation capability is corrupted and proper cleaning is not possible anymore.This is clearly given in ifu on page 1, 5 safety instructions, second warning, and page 2 seventh warning.Special this would have led to detect the damage straight after the procedure and prevented the patient from injury.The device in question has been in service for near 12 years.".
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We received a vigilance report from our manufacturer in (b)(6) which was filed with the national competent authority, (b)(6) in (b)(6).Allegedly, a female patient underwent a lap chole procedure on (b)(6) 2018.A month after the procedure, the patient complained about abdominal pain in the operated region.A subsequent ct scan showed a 4mm metal fragment situated below the umbilicus.A second procedure to remove the fragment was performed on (b)(6) 2018.
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