It was reported to aesculap ag that a disposable bipolar metz scissor 5/310mm (part # pl700) was used during an unknown procedure performed on (b)(6) 2021.According to the complainant, the tip of the outer shaft was split.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).
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Investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.Ceramics are broken probably due to an overload situation, e.G.Torsion or leverage during handling.The broken ceramic in combination with the contamination caused leakage currents in the instrument.These currents generated heat, which caused damage to the insulation.To avoid damage to the working tip, especially to the ceramic insulation: do not apply excessives forces and protect the working tip from impacts and knocks (as noted in the instructions for use (ifu)).Batch history review - the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar compplaints against the same lot number(s) with this error pattern.Possible.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 3(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.
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