COVIDIEN, FORMERLY US SURGICAL A DIVISON IDRIVE ULTRA POWERED HANDLE 1; STAPLE, IMPLANTABLE
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Model Number IDRVULTRA1 |
Device Problem
Unintended Arm Motion (1033)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/22/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device has not been received.A supplemental report will be sent upon completion of investigation if device is received.
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Event Description
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According to the reporter, during a laparoscopic low anterior resection, the idrive began articulating side to side on its own.It stopped and the status indicator light illuminated blue.A new device was used to complete the surgery with no further incident.There was no delay, no adverse event, and no injury reported.
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Manufacturer Narrative
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(b)(4).Devices idrvultra1, egiaadapt have been received but evaluation not yet begun.A supplemental report will be sent upon completion of investigation.
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Manufacturer Narrative
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(b)(4).Device evaluation summary: post market vigilance (pmv) led an evaluation of one idrive ultra powered handle and one endo gia adapter.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, engineering review of the product and an evaluation of the returned device.A visual evaluation of the adapter noted no visual abnormalities.Functional evaluation did not replicate the reported conditions.However, two cracked solder joints were detected on the mma board.These cracked joints are the probable cause of the reported condition.A product enhancement has been implemented to prevent this condition from re-occurring.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
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Search Alerts/Recalls
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