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Model Number WB991036 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Blood Loss (2597)
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Event Date 09/22/2020 |
Event Type
Injury
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Manufacturer Narrative
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The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient¿s outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
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Event Description
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Olympus was informed that after an unspecified therapeutic polypectomy procedure, bleeding occurred and the patient suffered from abdominal pain.However, the patient refused readmittance to hospital and her condition then improved on its own.No further information was provided.
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Manufacturer Narrative
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The suspect medical device was not returned to the manufacturer for evaluation/investigation.Therefore, the investigation/evaluation was performed exclusively on the basis of the information provided.According to the information provided,a periodic safety check (psc) was performed with the generator, where all tested parameters were found to be within specification.No defect, failure or malfunction could be determined.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected serial number of the hf generator without showing any abnormalities.Based on the information available, the exact cause of the reported phenomenon and the patient¿s outcome could not be conclusively determined.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.
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Search Alerts/Recalls
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