Model Number GF-UCT180 |
Device Problems
Peeled/Delaminated (1454); Defective Component (2292)
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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 received and evaluated at rrc (regional repair center) olympus (b)(4).Device evaluation found gap of adhesive on the distal end.Stain could enter inside the lens through the gap.The acoustic lens were found damaged.The customer reported issue could be confirmed.Further inspection of the device, the following findings were noted below: biopsy channel - perforated.Image guide cover lens -damaged.Image guide cover lens -scratched.Distal end -damaged.Light guide bundle -fiber breaking.Connecting tube deposit-scratched.-grip unit scratched: scope body damaged, scratched, suction cylinder nut painting peel off: scope cover scratched.Universal cord scratch, squeezed.El-connector unit corroded.Angulation wire play.Probe unit piezo elements defective.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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Event Description
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As reported, the distal end is leaky.The issue found during an unknown event.There is no patient involvement associated on this reported event.No user injury reported.Device return evaluation found gap of adhesive on the distal end.The acoustic lens rubber (pink probe) was damaged.
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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 and to correct information provided on the initial report.The following sections were corrected: 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 legal manufacturer's investigation, several damages were observed in the distal end.Therefore, it was determined that it is likely possible that external force was applied to the distal end such as shock caused by dropping and knocking the endoscope to a hard surface or object (handling issue).However, the cause could not be identified.The instruction manual identifies the following related verbiage which may have prevented the phenomenon: ¿do not apply shock to the distal end of the insertion section, particularly the ultrasound transducer and the objective lens surface at the distal end.Visual abnormalities may result.¿ olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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