Model Number JK100 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing site 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 that there was an issue with jk100 - filter retention plate.According to the complainant, black particles were detected.Hospital says getting micro black flakes which they believe are from basket feet and/or retention plates.The complaint device was returned to the manufacturer for evaluation.There was no described patient harm.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).
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Event Description
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Involved components: jn440 - bottom f/1/1 cont.Perforat.Height:90mm - lot unknown, jn441 - bottom f/1/1 cont.Perforat.Height:120mm - lot 52588251, jk441 - bottom for 1/1 container height:120mm - lot 52582372, jk489 - full-size lid w/retention plate silver - lot 52582372, jf223r - 1/1 size perf basket 540x253x76mm - lot 52685831, jf112210 - foot for perforated baskets - lot unknown, jk489 - full-size lid w/retention plate silver - lot 52591143, and jk489 - full-size lid w/retention plate silver - lot 52631606.
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Manufacturer Narrative
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Investigation results: visual investigation: all products arrived in a decontaminated condition.The leading devices, jk100, show water spots and partly corrosion.The container trays, lids, and the basket neither show black particles, nor any residues on their surface.The surface of these products show signs of use, in the form of scratches on the anodized coating.The investigation was carried out visually.No black particles could be determined on the provided products.The articles show normal signs of use.The filter holders have water spots and partly corrosion.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device was 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.Explanation and rationale: without further knowledge about the circumstances we assume, that a too high force was applid on the jaw during surgery.A material failure or a manufacturing error can be excluded.Conclusion and measures / preventive measures: due to the current deviation and according to the explanation above, the root cause of the problem is most probably reprocessing-related.Based upon the investigations results a capa is not necessary.
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Search Alerts/Recalls
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