Model Number CLV-190 |
Device Problem
Crack (1135)
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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 device was returned to olympus for evaluation and the evaluation found the front panel mouth was damaged, inside the bottom of the chassis was rusted, the front panel side chassis rusted, top cover was rusted, the lamp door rusted.The power switch housing had a crack; worn-out socket slider switch caused an intermittent use of high intensity mode; corrosion inside scope socket tubing; the image quality was bad on the functional control; the lamp had insufficient heat compound.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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Event Description
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The customer reported to olympus, the light source's image quality was bad and it kept coming and going.The customer replaced the light but the same issue was still occurring.The issue was found during multiple diagnostic procedures.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: a power switch malfunction.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
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Event Description
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The customer reported event occurred in the middle of a therapeutic endoscopic retrograde cholangiopancreatography, which was completed without delay.The patient was under anesthesia.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the correction of the initial mdr and the legal manufacturer's final investigation.Corrected fields: b5/d10 (information was inadvertently missed on the initial).A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over nine (9) years since the subject device was manufactured.The customer reported complaint of bad image was not confirmed.Based on the results of the investigation, the root cause of the power switch malfunction (cracks in the housing) could not be determined.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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