Model Number IPN928809 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/11/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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It was reported " the clips did not hole on to the tissue of the patient.So clips were removed from the patient".Additional information states that there was no injury or consequence to the patient.To complete the procedure, another device was used.
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Event Description
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It was reported " the clips did not hole on to the tissue of the patient.So clips were removed from the patient".Additional information states that there was no injury or consequence to the patient.To complete the procedure, another device was used.
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Manufacturer Narrative
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(b)(4).The reported complaint of "loaded clip is insecurely seated" could not be confirmed.An unopened representative sample was returned in place of the actual sample that resulted in the complaint issue.All clips were manually loaded into the jaws of the applier and were successfully applied to over-stressed surgical tubing without breaking or falling out of the applier.No functional issues were found with the returned clips.A device history record review was performed on the device with no evidence to suggest a manufacturing related cause.The probable cause of this complaint issue could not be determined based upon the information provided and without the actual sample.Teleflex will continue to monitor and trend on complaints of this nature.
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Search Alerts/Recalls
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