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Model Number A0358 |
Device Problems
Sparking (2595); Output Problem (3005); Temperature Problem (3022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/05/2022 |
Event Type
malfunction
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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 user's experience 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 an unspecified therapeutic laparoscopic surgery, the area near the connection between the hf-cable and the hf-electrode popped and a spark occurred.Before this happened the surgeon had felt the handle of the hf-electrode to be hot and the output performance of the electrode to be weaker than normal.The surgeon then replaced both the hf electrode and the hf-cable.The intended procedure was completed and there was no report about an adverse event or patient injury.
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Manufacturer Narrative
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Additional information: h4 - device manufacturer date.Device evaluation: the suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus medical system corporation (omsc), japan (returned to omsc on 2022-08-18).During the evaluation at omsc the hf-cable was found to be broken/separated on the instrument connector side.The reported issue is a known fault pattern.Age-related wear and tear in connection with a repeated tensile/bending load most likely caused single or all wires inside the cable to break.When the hf generator is activated, this can result in a voltage flashover in the damaged area.According to the article¿s lot number, the hf cable was manufactured in 2015.It therefore must be assumed that the hf cable was used longer than the 12 months the cable is designed for.Thus, this event/incident can most likely be attributed to age-related wear and tear in connection with improper handling by the customer and thus to use error.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the hf cable without showing any abnormalities.The case will be closed on olympus side with no further actions.However, 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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