Model Number GF-UCT180 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The device was returned to the olympus (b)(4) incorporation for evaluation.The control body of the was found to have a gap at the distal end.In addition there was a cut on the probe of the scope.The most likely cause for the reported event is mishandling.The instruction manual states "do not strike, hit, or drop the endoscope's distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope's distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.".
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Event Description
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This is an asset return which was found to have a reportable malfunction during estimation.There was no other device issue or patient injury reported.
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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.The following sections were updated: g4, g7, h2, h4, h6, h10.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the probable cause of the damage is likely an external force was applied to the acoustic lens damaging it and resulting in scratches.There was also additional damage observed to the curved part, which was likely due to an external force being applied.It is also possible the amount of use and age of the device (over 7 yeas) may have led to degradation, as well.The instructions for use (ifu) states: "inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.".
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Search Alerts/Recalls
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