Model Number GF-UCT180 |
Device Problem
Material Separation (1562)
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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 event date is (b)(6) 2021, when the gap was noted on the probe adhesive.The reporter¿s contact information, occupation and health profession are unknown at this time.Further inspection of the returned device found damage to the scope¿s acoustic lens.Defects were noted on the cementing of the insertion part of the bending section rubber.The connecting tube was scratched and play was noted on the scope¿s angulation wire.The cause of the physical damage to the scope cannot be determined at this time.An investigation is ongoing to obtain additional information regarding the reported event.If additional information is received this report will be supplemented accordingly.
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Event Description
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The customer reported that the scope was ¿dripping.¿ there was no reported patient involvement.The device was returned to the regional repair center (rrc) and found a gap on the probe¿s distal end adhesive.This report is being submitted to address the distal end gap found on the probe¿s adhesive.
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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 correction to g2.G2 - added the country austria.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.Based on the results of the investigation, the cause of the forceps cover glue peeling likely occurred due to an external force applied to the distal end.The specific root cause could not be determined at this time.The following information is stated in the instructions for use which may have prevented the event: "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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Manufacturer Narrative
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Correction to g3 of the initial medwatch.The aware date should be 07-nov-2021.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.
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Search Alerts/Recalls
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