OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE
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Model Number TB-0535FCS |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The coating of the grasping section was partially missing.The manufacturing record was reviewed and found no irregularities.This type of the event is most likely related to the operator's technique.Based on the past similar cases, it was known that the coating of grasping section was damaged when the user scraped tissue or coagulum on the grasping section with a sharp object.The instruction manual of the device has already warned as follows; *if the grasping section, metal-exposed area around it or the probe tip gets filthy during treatment, wipe it with a soft object such as a piece of gauze or a brush.Do not attempt to scrape it with a sharp object such as a scalpel or the tip of tweezers.Otherwise, the grasping section, metal-exposed area around it, the fluorine resin part, a coated surface or the probe tip may be scratched and damaged, which may lead to fall-off of the damaged part into the body cavity or burns of the tissue by a high-frequency leak current output due to destruction of the insulation structure.
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Event Description
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During a laparoscopic assisted distal gastrectomy, the subject device was used.After 90 minutes of use, the open circuit error,the probe damage error, the ultrasonic level error and the seal and cut short circuit error occurred.The user exchanged it with the 3rd device of tb-0535fcs and continued the procedure.However, it was reported that the same error occurred.The procedure was completed with the 3rd device.There was no patient injury reported.On december 19, 2017, olympus medical systems corp.(omsc) found that the coating of the grasping section was partially missing for the second device.This is the report regarding the missing of the grasping section coating of the second device.
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