It was reported on october 6th that they had experienced multiple loop breakages.I visited on friday 7th and spoke to the customer directly.He reported that they converted from holep (using a laser) to a turp due to a bleed and used 3 loops and 1 ball.The procedure took 3 hours though i couldn't ascertain as to how long the resection part was.Upon questioning the patient had not had any previous prostate surgery and started as a standard case.He was not sure if it was a large prostate, i would assume it would have been.The loops failed inside the patient and had to be removed endoscopically.The autocorrect setting were on standard and not changed during the case.The nurse was unsure how often the malfunction occurs with the product.After converting from holep to bipolar.Cutting loops and roller balls for bipolar diathermy started breaking and/ or melting down.We finished the procedure.After this, he was transferred to a different hospital where they extracted more metal bits from his prostate.The patient was fine and was discharged from the hospital.
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Two electrodes have been sent back - one is broken at the working electrode - one is used but functional.The used one shows some bending in the insulation as well as a scratch in the yellow insulation of the neutral electrode.The broken one shows the break at the end of the working electrode towards the yellow insulation on the power-supplying side.The yellow insulation on the neutral electrode shows a similar scratch in the same position as before.The broken surface has the appearance of a forced fracture.Device history records (dhr), and recent product or process changes were reviewed.According to the results of the device history review, there was no indication of a manufacturing failure.The most probable root cause is user-related.Both electrodes show signs of mechanical overload (bending, scratches).So, most likely, more force than appropriate has been applied.Internal karl storz reference number: (b)(4).
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