OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE; WORKING ELEMENTS (MONOPOLAR, BIPOLAR, FOR KNIVES, FOR PROBES)
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Model Number WA22367A |
Device Problems
Output Problem (3005); Activation Problem (4042)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 12/15/2021 |
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 during a therapeutic hysteroscopic procedure it was not possible to effectively cut tissue and stop the bleeding.Error e006 was issued on the hf generator due to poor contact between electrode and hysteroscope base.The surgeon then used a forceps to bend and firmly connect the electrode to the base of the hysteroscope.The intended procedure was then completed.However, the failure led to a significant prolongation of the surgery time and significantly increased bleeding.
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Manufacturer Narrative
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The suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the evaluation/investigation was performed exclusively based on the available information.The exact cause of the patient¿s outcome could not be conclusively determined.However, based on the information provided, we assume that the electrode was not installed properly and/or that its secure fit was not checked correctly before the procedure, which most likely led to the damage of the internal electrical contact.Due to insufficient contact between the electrode and the internal electrode contact, the generator then correctly displayed error message e006.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the working element without showing any abnormalities.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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