OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE X; ULTRASONIC SURGICAL DEVICE
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Model Number TB-0520FCX |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/10/2019 |
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 tissue pad of the subject device was severely worn and the proximal side of tissue pad was stuck out.The coating for electric insulation of the probe was partially missing.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the coating for electric insulation of the probe and the tissue pad were damaged since the user continued to activate output without grasping tissue (including after the tissue already cut).The above device handling has warned in the instruction manual as follows: do not activate output in seal & cut mode while the grasping section is closed without contacting tissue or vessel, or ensuring that tissue is transected.Otherwise, a local increase of the temperature due to a friction between the probe tip and the grasping section may result in various forms of damage in the probe tip and/or the tissue pad, such as premature wear, breakage, deformation, and/or falling off inside the body cavity and/or partial separating.
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Event Description
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During a procedure in pylorus side, the subject device was used.Open circuit error occurred.The tissue pad of the subject device was partially separated.The intended procedure was completed with another device.There was no patient injury reported.On jun 24, 2019, olympus medical systems corp.Found followings.The tissue pad of the subject device was severely worn.The proximal side of tissue pad was stuck out.The coating for electric insulation of the probe was partially missing.This is the report regarding the severely worn tissue pad, the protrusion of the tissue pad, and the missing of the probe coating.
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