Model Number JF-260V |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The subject device was returned to olympus service operation repair center (sorc).Sorc checked the subject device and found a scratch on the instrument channel.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
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Event Description
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Olympus medical systems corp.(omsc) was informed from the user that during the unspecified timing, the instrument channel of the subject device was clogged with the double layer stent (10fr).The event date was unknown.Other detailed information was not provided.There was no report of patient injury associated with the event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) re-evaluated the event reported in the initial report and determined that the failure mode is not a mdr reportable malfunction.Therefore, this report is being submitted to retract the mdr on the event.
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Manufacturer Narrative
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This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.Correction: this is a reportable malfunction.The device was returned to olympus for evaluation where service was unable to confirm the customer's complaint, though it was determined the occurrence was likely.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 is likely that the event occurred due to deformation of the forceps channel, breakage of the instrument, or foreign material in the forceps channel.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "·operation manual 3.8 inspection of the endoscopic system - inspection of the instrument channel and forceps elevator ·operation manual important information ¿ please read before use - precautions ·operation manual 3.6 inspection of ancillary equipment ·operation manual 4.3 using endotherapy accessories ·reprocessing manual 5 reprocessing the endoscope (and related reprocessing accessories) ·reprocessing manual 7 reprocessing endoscopes and accessories using an aer/wd" olympus will continue to monitor the field performance of this device.
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Manufacturer Narrative
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This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 9610595.
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Search Alerts/Recalls
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