Model Number 173016 |
Device Problems
Detachment Of Device Component (1104); Component or Accessory Incompatibility (2897); Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/16/2018 |
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 the procedure, the device was difficult to toggle and load.It was also stated that the needle from the reload also fell into the cavity of the patient.There was no reported patient outcome.
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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.There was no evidence of malfunction of the device.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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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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