Model Number BB542 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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It was reported that there was an issue with a carbon steel scalpel blade.According to the complaint description the blade broke in mouth of the patient during surgery.The customer claims that there is a high risk of loosing the broken piece in patients mouth.There was no patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).
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Manufacturer Narrative
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Investigation results: visual investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.The scalpel blades sent as opened and "used" samples for demonstration to the sales representative.Furthermore unopened blades have been sent back.During a test with unopened samples the deformation and breakage of the tip could be reproduced by tipping the tip with force to a hard surface.The microscopic investigation showed a deviation of the tip shape from the shape in the drawing.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that there is one similar complaint filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity x probability of occurrence) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: the form of the scalpel blades tip is not according to the specification and the tip is very flexible.This is caused by a manufacturing issue and will be investigated by the manufacturing plant.Based upon the investigations results there is capa is not necessary.An analysis and corrective action has been requested to the production plant.
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Search Alerts/Recalls
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