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Model Number H749236310020 |
Device Problem
Air Leak (1008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/19/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Event Description
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Same case as mdr id: 2134265-2017-07814.It was reported that there were air bubbles at the burr.A 1.25mm rotalink¿ plus were selected for use.Upon platforming, outside patient's body, saline leak was noted on the advancer and bubbles went up to the burr.In addition, the sleeve of the connection was noted to be loose when the device was checked and the physician suspected that the connection between the burr and the motor was not hermetically closed.The device was replaced with another of the same rotalink device; however the same issue occurred.The procedure was not completed due to the event.There were no patient complications reported and the patient's condition was stable.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.The advancer, coil, sheath, handshake connections, burr, and annulus were microscopically and visually examined.The advancer unit and burr unit were received detached.Inspection of the device revealed that the handshake connection was bent.The advancer knob was received tightened in a forward position.The handshake connection was also bent at the connection.Functional testing was performed by connecting the rotalink plus device to the rotablator control console system.There were no abnormal noises, leaks, and the device did not run; so it wasn¿t able to get any speed.The advancer was dismantled and the turbine was found to be corroded and the ultem was found to be melted.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
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Event Description
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Same case as mdr id: 2134265-2017-07814.It was reported that there were air bubbles at the burr.A 1.25mm rotalink¿ plus were selected for use.Upon platforming, outside patient's body, saline leak was noted on the advancer and bubbles went up to the burr.In addition, the sleeve of the connection was noted to be loose when the device was checked and the physician suspected that the connection between the burr and the motor was not hermetically closed.The device was replaced with another of the same rotalink device; however the same issue occurred.The procedure was not completed due to the event.There were no patient complications reported and the patient's condition was stable.
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Search Alerts/Recalls
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