GYRUS ACMI L.P. SUR-CATCH HELICAL BASKET, 3.0FR,3PR,5CM TIP; DISLODGER, STONE, FLEXIBLE
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Model Number 5711012 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/06/2022 |
Event Type
malfunction
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Event Description
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Olympus (oekg) was informed by quality assurance specialist at the user facility that the customer received the sur-catch helical basket which ¿appeared to have moulding defects during packing from the factory¿.The customer problem was found during a receipt inspection.No death, injury or harm was reported to olympus.
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Manufacturer Narrative
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The subject device was returned to the olympus repair center (oekg).Also, images were provided of the device in sealed packaging.The packaging of the device shows there is slight warping.The device history records for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.A total of 12 units were produced under this lot number with no associated non-conformances, reported scrap or recorded process deviations relating to the reported failure.The investigation is ongoing.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it¿s likely the damaged packaging was due to transportation and/or storage at high temperatures.The root cause of this event was unable to be identified.The following is included in the instructions for use: ¿should the product or its container be received damaged, do not use.Sterile units are ready for use if the package is intact.¿ olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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