Model Number FORCE SENSOR |
Device Problem
Misconnection (1399)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been evaluated yet for investigation purpose.Once the evaluation will be performed, a follow-up medwatch report will be submitted.
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Event Description
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During an applicative testing of the device performed by a medtech representative, the force sensor cable got detached and entangled in the robot arm.The force sensor cable was not damaged but its connector was damaged.
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Manufacturer Narrative
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During the applicative test the field service engineer did not pay attention and the force sensor cable got entangled in the robot arm and the connection broke.The most probable root cause is a user error.
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Manufacturer Narrative
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This complaint is being remediated under an issue evaluation: complaints item numbers remediation.The item number was updated, the concerned medical device was the force sensor and not the rosa robot.
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Event Description
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During an applicative testing of the device performed by a medtech representative, the force sensor cable got detached and entangled in the robot arm.The force sensor cable was not damaged but its connector was damaged.
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Event Description
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During an applicative testing of the device performed by a medtech representative, the force sensor cable got detached and entangled in the robot arm.The force sensor cable was not damaged but its connector was damaged.
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Manufacturer Narrative
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The force sensor interface and interface block were returned for investigation on 09-nov-2021.However, the initial findings are not challenged by the investigation performed on these parts.Therefore, the most probable root cause remains a user error (during the applicative test the field service engineer did not pay attention and the force sensor cable got entangled in the robot arm and the connection broke).
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Search Alerts/Recalls
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