Model Number MAJ-891 |
Device Problem
Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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In speaking with olympus technical support via the phone, the olympus sales representative was advised the customer would need to order a replacement.It was reported the subject device would not be returned for evaluation, therefore the device evaluation could not be completed at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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The olympus representative reported on behalf of the customer, during preparation for use for a diagnostic cystoscopy procedure, the forceps/irrigation plug (isolated type) was unable to be reassembled.The threaded side would not go together.The intended procedure was completed with another forceps/irrigation plug with no surgical delay.No patient harm reported.The customer had used the item for several months.
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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.The dhr was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.Based on the results of the investigation, it is likely that one of tightening rings, biopsy ports, or tightening ring attachment part of housing was damaged or foreign material adhered to any of the above contact surfaces during assembly.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.
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Search Alerts/Recalls
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