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Model Number WA00014A |
Device Problems
Break (1069); Mechanical Problem (1384); Arcing (2583); Sparking (2595)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Event Description
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Olympus was informed that at an unknown date/time, the bipolar hf-cable burnt through after it made a popping sound and sparked.No further information was provided but there was no report about an adverse event or patient 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 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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Manufacturer Narrative
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The suspect medical device was not returned to the manufacturer for evaluation/investigation but to an olympus regional repair center (rrc) in france (returned to rrc on 2022-09-22).The evaluation at the rrc confirmed that the hf-cable was broken and the blue plug system is completely broken off.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 june 2021.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.The broken plug system was caused by excessive force and is therefore attributed 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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