Model Number FC700SU |
Device Problem
Product Quality Problem (1506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
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Event Description
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It was reported to aesculap ag that a pas-port proximal anastomosis system (part # fc700su) was used during an on pump beating procedure performed in early (b)(6) 2021.According to the complainant, during the procedure, after rotating the device knob, only a hole was made in the aorta.The procedure was successfully completed using another manufacturer's device.The complaint device has not been returned to the manufacturer for evaluation.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).
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Manufacturer Narrative
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Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a product safety case (b)(4) was initiated.Any action regarding capa will be addressed with this case.A product recall (fsca-255) was initiated.Product not sold nor marketed any longer.
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Search Alerts/Recalls
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