Model Number GF352R |
Device Problem
Break (1069)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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 gf352r - ferg-frazier suct 7fr110mm wrk-lgt.According to the complaint description, during a surgery, as the cannulas were used in the usual way, they broke supposedly without any force exerted from the medic and almost falling inside the operating field.Each cannula was, allegedly, broken at different procedures and used by different doctors.There was no described patient harm.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00284 ((b)(4) + gf350r), and 9610612-2021-00272 ((b)(4) + gf353r).
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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 2(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.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 capa is not necessary.
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Event Description
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Associated medwatch-reports: 9610612-2021-00284 (400506558 + gf350r) 9610612-2021-00272 (400506559 + gf353r) 9610612-2021-00271 (400506557 + gf352r).
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Search Alerts/Recalls
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