Model Number A22251C |
Device Problems
Detachment Of Device Component (1104); Component Falling (1105)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/10/2015 |
Event Type
malfunction
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Manufacturer Narrative
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The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined at this time; however this type of damage is most likely related to the operator's technique.The instruction manual contains several caution statements in an effort to prevent damage to the electrode."when attaching the electrode, make sure not to push it too forcefully into the working element.When checking the locking of the electrode, make sure not to pull too forcefully.Otherwise the electrode may be damaged." if additional information or if the device is returned at a later time, this report will be supplemented.
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Event Description
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Olympus was informed that during an endometrial ablation procedure, the ball component of the electrode came off and fell inside the patient's uterus.The ball was retrieved from the patient.The procedure was successfully completed using a different but similar device.There was no patient injury reported.It was further reported that the ball tip was discarded.No additional information was provided.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the device evaluation results.The device was returned to olympus for evaluation.The evaluation confirmed the reported electrode damage.A visual inspection was performed and found the electrode wire melted.Additionally, the electrode ball was found missing and not returned for evaluation.The most likely root cause could be attributed to extended high frequency (hf) output setting.The instruction manual contains several warning and caution statements in an effort to prevent damage to the electrode."improper use of hf current can cause endogenous or exogenous burns, and explosions.Visually inspect the instrument.Warped electrodes, defective insulation and broken, cracked, or irregular cutting loops represent a danger for both the patient and the surgeon and must not be used.Never try to bend irregular cutting loops into shape! if the instrument is damaged or does not function properly, replace it.When attaching the electrode, make sure not to push it too forcefully into the working element.Otherwise the electrode may be damaged.".
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information received from the oem.The oem performed a quality control review for the reported lot number of the hf resection electrode that was used and no anomalies were found related to function and safety.The oem evaluation found the present failure mode was typical for unintended contact with other metal parts, e.G.Surgical instruments.Therefore the root cause for the reported event was attributed to use error.
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Search Alerts/Recalls
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