The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome 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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Olympus was informed that at the end of a therapeutic laparoscopic cholecystectomy procedure, the patient sustained a burn on the skin around the trocar tube while the operating surgeon was treating a bleeding of the abdominal wall by electrosurgery.It was then noticed that a part of the shaft's insulation had peeled away and that the underlying metal was in direct contact with the patient's skin.However, no fragment broke off and fell inside the patient.The burn was treated by excision and suturing.No further information was provided but the intended procedure was successfully completed and the patient is reportedly doing well.
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Additional information: device manufacture date.Device evaluation: the suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus medical systems corporation (omsc), (b)(4) (returned to omsc on 2016-03-08).The evaluation/investigation confirmed that the insulation in the middle of the shaft has partially melted.Furthermore, there are several scratches on the insulation.The cause of this damage is thermal overload (excessive high-frequency output power) and mechanical impact (excessive force).As clearly stated in the instructions for use, the shaft must be inspected before each use.It has to be checked that the product has no dents, cracks, kinks, deformations, deep scratches, corrosion, missing or loose parts and insulation defects (holes, cuts, cracks, shrinking, strong discoloration).A damaged product must not be used.The user apparently did not follow these instructions, since he reportedly used the suspect medical device despite damage at the shaft's insulation.Furthermore, the cause of this damage is thermal overload and mechanical impact.Therefore, this event/incident was attributed to abnormal use/off-label use.The case will be closed from olympus side, but the reported phenomenon will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results and pro re nata retrained to correctly inspect, test and use the olympus medical devices.
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