Model Number 176645 |
Device Problems
Break (1069); Difficult to Open or Close (2921)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/19/2018 |
Event Type
malfunction
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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, before the laparoscopic pouch surgery, during the preparation phase of the device, it was realized that the jaws of the device were separated/split, therefore a second device was opened, the dissector jaws did not close as mutual.These devices were not used in the case.This problem would have caused unwanted tissue damage and injury.The case was completed by using a new device.There was no patient injury.
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Manufacturer Narrative
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Post market vigilance (pmv) led an evaluation of two devices.No abnormalities were found during visual inspection and functional testing of the returned product.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Post market vigilance (pmv) led an evaluation of two devices.A review of the device history record indicates the product was released meeting all manufacturers¿ 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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