OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR, 4 M, UES-30/-40, ERBE INTL. AND VALLEYLAB (NEW) HF-UNIT.
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Model Number A0393 |
Device Problem
Thermal Decomposition of Device (1071)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned to olympus for evaluation.The exact cause of the reported event could not be determined, however, based on similar reported device complaints improper maintenance could not be ruled out as a contributing factor as the instruction manual contains several warning statements in an effort to prevent damage to the cable.¿visually inspect the cable and the plugs for irregularities on the surface.Do not use a cable with brittle or defective insulation.Replace the cable.In order to plug or unplug the cable, always pull at the plug.Never pull at the cable or risk of damaging the cable may occur.Also, when used as intended this product is more or less subject to wear depending on the intensity of use.Do not use the hf cable after one year of use.¿.
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Event Description
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Olympus was informed that during a therapeutic gynecological ablation resection procedure, the hf-cable sparked and then blew apart at the connection site.There was smoke noted; however, no flames were observed and the operating room was not evacuated.The non-olympus generator settings were 80 cut/80 coag with no alerts or alarms observed.Intended procedure was completed with a similar device.There was no patient injury reported.Additionally, the device was inspected prior to the procedure with anomalies noted.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information from the original equipment manufacturer.The oem performed a manufacturing and quality control review for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.
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Manufacturer Narrative
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This supplemental report is being submitted to report the device evaluation results.A visual inspection on the returned device found the cord completely detached from the plug that connects to the hf generator unit.Visual inspection of the damage area under a microscope reveals traces of burnt, charring deposit on the internal wirings and insulation as signs of thermal damage.Due to the damaged cable, it could not be tested for the functionality.Based on the investigation findings and similar reported events, the reprocessing, moisture invasion, or mechanical stress due to cable being pulled that could have damaged the internal wirings of the hf cable; so when the hf current was activated, the internal wirings became burst and broke.Note the hf cable should be disposed of after 12 months of use and thoroughly inspect the product for traces of wear before use.
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