Model Number JS489 |
Device Problem
Problem with Sterilization (1596)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2021 |
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 js340 - s2 1/2-cont.Bottom perfor.H88mm h2o2.According to the complaint description, the containers failed multiple times in nx100 flex, and standard / 100s sterrad cycles.Customer had to hand wash container and run through mechanical wash x10 before js340 passed, js440 still failing.The delay was due to the repeated failure of the container in low temp sterilizer.No patient involved, but the item needed to be blue wrapped in order to be properly sterilized.There was no described patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00216 ((b)(4) + js440).
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Manufacturer Narrative
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Updated b5: product changed.Updated d1 + d4: product name and model number, udi.Updated d9: date of device returned to manufacturer.Updated h6: codes.Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file - no malfunction or serious injury.Investigation results: visual investigation: the products arrived in a decontaminated condition with whitish gray corrosion.The investigation was carried out visually and microscopically.We made a visual inspection of the products.Here we detected a whitish gray corrosion of the products.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 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.Based upon the investigations results product safety case (psc) was initiated.Any action regarding capa will be addressed with this case.
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Event Description
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Product changed from (b)(6) to (b)(6) - s2 1/1-container lid h2o2.Associated medwatch-reports: 9610612-2021-00216 (400504817 + (b)(6)) 9610612-2021-00217 (400504818 + (b)(6)).
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Search Alerts/Recalls
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