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Model Number GF-UCT260 |
Device Problems
No Display/Image (1183); Device Contamination with Chemical or Other Material (2944); Material Split, Cut or Torn (4008); Failure to Clean Adequately (4048)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/22/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device was returned to olympus for evaluation.During inspection and testing, the allegation of ultrasound image did not reflect was not confirmed.The allegation of scratches on the surface of the ultrasonic probe was confirmed.Acoustic lens had a chip.In addition, due to a pinhole on channel tube, water tightness was lost.Due to wear of angle wire, bending angle in up direction did not meet the standard value.Due to wear of angle wire, the play of up/down knob was out of the standard value.Adhesive on bending section cover was detached.Adhesive on bending section cover had a crack.Ultrasonic transducer had corrosion.Mouthpiece was loose.Connecting tube had a scratch.Connecting tube had a wrinkle.Distal end had a scratch.Distal end had a dent.Due to wear of lock engagement lever, up/down knob could not be locked securely.Protector of universal cord on control section side had a scratch.Paint on air/water cylinder was peeled.Objective lens had a scratch.Objective lens had a crack.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.
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Event Description
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An olympus employee reported on behalf of the customer, the evis lucera ultrasound gastrovideoscope had scratches on the surface of the ultrasonic probe and ultrasound image did not reflect.There was no user or patient harm associated with this event.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.During inspection and testing, distal end of the device had foreign material attached.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported device problem.The dhr confirmed that the subject device was shipped in accordance with the specifications.The root cause of no ultrasound image and scratches on the ultrasonic probe surface could not be identified.The foreign body could not be identified.The cause of the retained foreign body in the device could not be identified.The instruction for use provides the following: ¿warning: do not strike or drop the tip of the endoscope, soft part, curved part, operating part, universal code, or scope port.Do not bend, pull or twist the cable with a strong force.Damage to the device may result in injury to the body cavity, burns, bleeding, perforation, or dislodgement of parts.¿ olympus will continue to monitor field performance for this device.
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Event Description
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Additional information was provided regarding this event.The event occurred during preparation for use.The intended procedure was a therapeutic endoscopic ultrasound fine-needle aspiration.There were no delays, and the procedure was completed using another device.There was no user or patient harm associated with this event.The customer was able to clean, disinfect and sterilize the subject device prior to requesting repair.It is unknown when the foreign object adhered to the scope.It is unknown what the foreign material is.There was no delay between the end of clinical use and the start of pre-cleaning.There were no abnormalities in the accessories used for reprocessing.The air/water nozzle was wiped/brushed with a gauze, brush, or sponge.
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Search Alerts/Recalls
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