Model Number KD-650Q |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause could not be conclusively determined.A supplemental report will be submitted, if additional and significant information becomes available at a later time.
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Event Description
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During an unspecified therapeutic, the distal knife of the subject device was fallen off into the patient.It was not reported whether the fragment was retrieved or not.No patient injury was reported.No further information was provided.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information based on the subject device.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.There were no defects affected to falling off.As the result of checking the manufacturing record of the same lot, there was nothing abnormal detected.Based on the evaluation of the subject device, there was no malfunction which caused or might cause the fragment to fall inside the patient.Therefore, we are retracting mdr.
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Search Alerts/Recalls
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