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Model Number 4K LAPAROSCOPE, 0°, 5.5MM X 300MM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Burn, Thermal (2530)
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Event Date 10/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
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Event Description
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It was reported that during a diagnostic laparoscopy procedure, the patient got burned.The burn was discovered by the patient after the surgery.The following devices were used during the procedure: ss9-gyw50w108 / batch wo155094, ar-3210-0030, s/n (b)(4), ar-3210-0006, s/n (b)(4), ar-3351-5500, s/n (b)(4).No further information has been made available.
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Manufacturer Narrative
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No problem found.The evaluation did not identify any issues relevant to the reported event for ar-3351-5500/1279082.
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Search Alerts/Recalls
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