Model Number FH913B |
Device Problems
Material Erosion (1214); Peeled/Delaminated (1454); Appropriate Term/Code Not Available (3191)
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Patient Problems
No Consequences Or Impact To Patient (2199); 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.(b)(4).
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Event Description
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It was reported that there was an issue with a rongeur.According to the complaint description the surface quality changed.After 9 times of preparation the coating dissolves and the surface condition has changed.There are also unevennesses in the material.Found prior to use.There was no patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00457 (b)(4), 9610612-2020-00459 (b)(4).
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Manufacturer Narrative
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Investigation results: the device was available for investigation.The device history records have been checked for all available lot numbers and found to be according to the specification, valid at the time of production.There are no further complaints registered against the same lot numbers.Based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage, and in case of the friction found on the sliding surface by insufficient lubrication.The signs of friction and scratches found on the surface/coating are signs for the contact of the surface with other instruments or other hard surfaces during the reprocessing or the usage of the rongeurs.Regarding the described issues with fibres coming from the gauze used for intra-operative cleaning we want to inform, that gauze is not suitable for such a cleaning, as edges coming from the geometry of the mouth are part of the design and are not avoidable.There is no indication for a material defect or manufacturing failure on the basis of the device history records.Based on the investigations and results of the 8d report no capa is necessary.
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Event Description
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The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00457 ((b)(4)- fh914b), 9610612-2020-00458 ((b)(4)- fh913b), and 9610612-2020-00459 ((b)(4)- fh912b).
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Search Alerts/Recalls
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