Model Number 173016 |
Device Problems
Break (1069); Component or Accessory Incompatibility (2897); Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 07/16/2019 |
Event Type
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 a total laparoscopic hysterectomy, the operator experienced difficulty in loading and unloading the device.It was noted that there was also difficulty in toggling the device.Needle tip also broke and fell into patient's cavity and was retrieved.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received with a needle loaded in its jaws.This needle was removed before investigation.Visual inspection of the returned device noted that there were no abnormalities that would have caused or contributed to the reported condition.The returned instrument was found to function properly and the test needle remained intact.No difficulty was experienced in loading, unloading or toggling the test needle in the returned instrument.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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