Model Number 173016 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/07/2018 |
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, during a laparoscopic paraesophageal hernia repair, the needle fell off into the cavity of the patient then the applier bent the needle.A grasper was use to retrieve it.There was no patient injury.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.No abnormalities were found during visual inspection and functional testing of the returned product.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.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 a laparoscopic paraesophageal hernia repair, the needle fell off into the cavity of the patient then the applier bent the needle.A grasper was use to retrieve it.A new endostitch was opened to resolve the issue.There was 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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Search Alerts/Recalls
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