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Model Number TJF-260V |
Device Problems
Material Twisted/Bent (2981); Unexpected Color (4055)
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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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This device is not sold in the u.S., but a similar device is.The device is returned, and an evaluation completed for it.Upon inspection and testing, it was observed that the inside of the light guide (lg) lens had color change.This is attributed to a gap in the adhesive, caused by stress, through which impurities can enter the inside of the lens.In addition, the forceps elevator wire has damaged with raised wire.This is attributed to mechanical or chemical stress applied by repeated use over a long period of time.Other observations for the device: angulation in the up direction is out of standards due to worn angle-wire; screen is partly dark due to scratch of charge couple device (ccd) lens; crease at the ccd lens; lg lens is broken; adhesive of distal end rubber coating (a-rubber) is broken; crumple at the connecting tube; suction cylinder is cut off; crumple at the universal cord; electrical connector is corroded; and scope cover is polluted.The user's complaint of the upward angulation was confirmed.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.
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Event Description
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Customer returned the device for evaluation and repair of the forceps elevator skipping and not having a smooth upward movement occurring during preparation for use.There is no patient involvement and no harm to any patient.The intended diagnostic procedure was completed without any problem or delay with another similar device.Upon evaluation of the returned device, it was observed that the inside of the light guide (lg) lens had color change.This is attributed to a gap in the adhesive, caused by stress, through which impurities can enter the inside of the lens.In addition, the forceps elevator wire has damaged with raised wire.This is attributed to mechanical or chemical stress applied by repeated use over a long period of time.This medwatch is being submitted for the reportable issue of lg lens color change on the inside and raised wire of the forceps elevator as observed during device evaluation.
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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 investigation.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 investigation, the root cause of the dirty lens was, the lg-lens glue had peeled by physical stress to the distal end or chemical stress due to chemical solutions used.Then humidity entered the lg-lens and caused corrosion.K-wire became snapped due to fatigue breakdown from repeated operation of the forceps elevator, then the k-wire became raised resulting from repeated reprocessing around the forceps elevator or attachment/detachment of distal cover olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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