OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, 45° NEEDLE, 24-28 FR., 12° AND 30°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES
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Model Number WA22355C |
Device Problems
Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/31/2018 |
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 hysteroscopic procedure, the needle tip at the distal end of the hf resection electrode broke off and a fragment fell inside the patient.The patient was then x-rayed and the fragment retrieved.No further information was provided and there was no report about an adverse event or patient injury.
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Manufacturer Narrative
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Device evaluation: the suspect medical device was not returned to the manufacturer for evaluation/investigation.Therefore, the evaluation is based on the information provided by the customer.According to the customer the needle tip at the distal end of the hf resection electrode broke off.The cause of this damage cannot be definitely determined, but it is most likely that the resection electrode was damaged as a result of mechanical overload by the application of excessive force.Thus, this event/incident was attributed to use error.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the resection electrode without showing any abnormalities.The case will be closed from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.
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