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Model Number LTF-S190-10 |
Device Problem
Peeled/Delaminated (1454)
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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 repair inspection confirmed the customer¿s reported problem as the bending section cover is wrinkled and scratched.The inspection also noted the bending section cover adhesive is chipped, the angle wire is worn and the up angulation is out of specification, and the free engage lever is worn and out of specification.The review of the device history records for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.The device was manufactured according to valid instructions and met all specifications.The investigation is still in progress; however, if additional information becomes available, this report will be supplemented accordingly.In general, the end-user 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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Event Description
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The customer endoeye flex deflectable videoscope was returned to the olympus repair center for deformation to the insertion section.During the inspection, olympus identified the adhesive was peeled off/missing around the objective lens at the distal end of the scope.No death or injury and no impact to patient or other has been reported to olympus.This report was submitted to capture the peeled off adhesive at the distal end found during inspection.
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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.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the objective lens glue peeled off due to stress of repeated use, external factors, or handling.The final root cause of this event was unable to be identified.The following is included in the instructions for use: ¿chapter 3 preparation and inspection, section 3.3 inspection of the endoscope: [inspection of the endoscope] 6 inspect the objective lens and light guide lens at the distal end of the endoscope for scratching, cracks, stains, gaps around the lens, or other irregularities.¿ olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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