Model Number 176645 |
Device Problem
Failure to Align (2522)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/12/2018 |
Event Type
malfunction
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Event Description
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According to the reporter, during laparoscopic cholecystectomy, the surgeon noted that there was misalignment of two devices.The procedure was completed with another device.There is no patient injury.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during laparoscopic cholecystectomy, the surgeon noted that there was misalignment of the tip of the two devices.The procedure was completed with another device.There is no patient injury.
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Manufacturer Narrative
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Additional information: evaluation summary post market vigilance (pmv) led an evaluation of one device.The device found to be functioning within specifications.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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