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Model Number TJF-160VR |
Device Problems
Material Frayed (1262); Material Split, Cut or Torn (4008)
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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 device was returned as part of the asset return process and other findings includes: the nozzle is shaved; the adhesive on the bending section cover is detached; the connecting tube has a buckling; the light guide cover glass has stain; the control unit is deformed; the switch box has a scratch; the universal cord has a scratch; the suction connector has corrosion due to water leakage; the electrical connector has corrosion due to water leakage; due to wear of angle wire, the bending angle in an up/down/right/left direction does not meet the standard value; due to wear of angle wire, the play of the up/down (right/left) knob is out of the standard value; due to fray of knob wire, the forceps raising angle does not meet the standard value.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
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Event Description
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A user facility returned the olympus asset, duodenovideoscope, to the olympus service center.Upon inspection and testing of the returned device, it was observed that the knob wire was found damaged.Some of the wire that composes the forceps elevator wire was raised due to a cut or fray.This report is being submitted for the reportable malfunction found during evaluation.There was no patient involvement.
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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 13 years since the subject device was manufactured.Based on the results of the investigation, the knob wire may have been damaged by repeated manipulation of the forceps elevator, the distal cover may have caught on the broken knob wire when the cover was attached, or the broken knob wire contacted a cleaning brush while brushing the distal end.However, specific root cause could not be determined.The event can be detected/prevented by following the instructions for use: the tjf-160vr operation manual provides detailed instructions for the device inspection in chapter 3, section 2.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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