Model Number IPN056405 |
Device Problem
Misfire (2532)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).The device history record of batch number provided has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No rejection report was originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our specifications.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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We had two misfire in a case last week.
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Event Description
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We had two misfire in a case last week.
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Manufacturer Narrative
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(b)(4).Additional information: the tech that was in the case just got back to me as i'm not the one actually in the room for this.She said it is hard to say if an injury was caused but it caused the case to be extended because of the incident.The punch did not make a clear cut, it went through, got stuck and tore off making the hole bigger than desired.Also caused for more than normal suture repair.It has happened twice with two different doctors.
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Search Alerts/Recalls
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