Model Number 174023 |
Device Problem
Failure to Form Staple (2579)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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, the device's staples were bent.There was no patient suffered blood loss or tissue damaged, no surgery had extended the surgical time due to damaged stapler.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, per additional information received used a new stapler in order to complete the case.Status of the patient: healthy.
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Manufacturer Narrative
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Post market vigilance (pmv) led an evaluation of one device.There were no visual or functional abnormalities observed during the product analysis.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.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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