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Model Number 174006 |
Device Problems
Loss of or Failure to Bond (1068); Positioning Failure (1158); Detachment of Device or Device Component (2907); Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/29/2019 |
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 laparoscopic inguinal hernia repair, the tacker did not fire and got jammed.Additionally, the fired tacks did not hold correctly onto the tissue and fell into the patient's cavity.However, it was retrieved.The surgeon used another tacker to complete the case.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.Visual inspection of the product noted the timing was disengaged.Additionally, the trigger was jammed.Functionally, the trigger of the instrument was actuated after disassembling the body from the tube.Tacks were jammed in the tube and did not deploy due to the timing disruption.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the reported condition is caused by an instrument that has been exposed to excessive force while applying helixes to a surface.If a helix is fired over improper surfaces it can provoke the exertion of excessive force to the handle causing the unit to disrupt the timing and to a possible jam.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.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 laparoscopic inguinal hernia repair, while the tacker is firing, tacks disengaged one by one.Tacks does not fixate and device got jammed.In addition, the fired tacks did not hold correctly onto the tissue and fell into the patient's cavity.However, it was retrieved by used of another device.The surgeon used another tacker to complete the case.There was no patient injury.
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Search Alerts/Recalls
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