OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, JOHANN, MONOPOLAR; ELECTROSURGICAL
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Model Number WA69310M |
Device Problem
Flare or Flash (2942)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2023 |
Event Type
malfunction
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Event Description
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It was reported to olympus that during a bariatric operation on january 20, 2023, the connection between the jaw and the stem ¿flared¿ and fell into the surgical field.The patient is fine, there are no injuries to internal organs.There was no injury or health damage due to the reported event.
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Manufacturer Narrative
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The device will not be returned to olympus for an evaluation.The investigation is still in progress; therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.
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Manufacturer Narrative
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This medwatch is being supplemented with additional information obtained and the manufacturer's final investigation results.The device was not return for an evaluation.The cause for the reported issue is very likely improper handling/excessive force by the user.The jaws are designed to grasp soft tissue.Improper handling (e.G.Grasping hard material, or twisting the item when grasping) might cause a deformation or breakage.A manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.Olympus will continue to monitor the field performance of this device.
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