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Model Number TJF-Q180V |
Device Problems
Crack (1135); Failure to Clean Adequately (4048)
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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 to olympus for evaluation and the customer's complaint was confirmed.In addition to the malfunction reported in section b5 the following findings were discovered; the red paint around suction cylinder was faded or missing, the angulation was reduced due to stretched angle wires, the insertion tube was deformed or snaky, the coating on the universal cord was peeled off, there was a gap of adhesive on the distal end, the knob wire was disconnected, and multiple parts of the scope had damage or deformation due to physical stress.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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Event Description
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The customer reported to olympus, the duodenovideoscope had a broken cable.The device was returned for evaluation.During the device evaluation, the following reportable malfunctions were found: a stained lens and a crack on the distal end of the device.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during 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 final investigation.Additionally, (h4) device manufacturer date was added and the following correction to (b5): it was stated that during the device evaluation, the following reportable malfunctions were found: a stained lens and a crack on the distal end of the device.Correction: the only reportable malfunction identified during the device evaluation was that the distal end was cracked.The stained lens was included in error.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, the cracked distal end may have resulted from physical or chemical stress.However, the specific cause of the damage could not be determined.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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