Model Number IPN915600 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that " during the insertion of the blade in the throat the blade broke at the level of the green plastic connection.Additional information: patient consequence was that there was a delay in the procedure as they had to try other blades.The entire blade was removed with no part left in the patient.It is reported that the patient is deceased but not as a cause of the incident.2 blades broke.Associated complaints 9681900-2023-00030, 9681900-2023-00031 and 9681900-2023-00029.
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Manufacturer Narrative
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Qn#(b)(4).Three samples were returned to the manufacturer for investigation.The manufacturer reported: "although the defective samples are received "disinfected not to be considered sterile" but the returned blades were still contaminated.We thoroughly rinsed the returned samples under tap water and disinfected them.The device was visually inspected.On one of the samples, there was no problem detected.The break point test has been performed on the client's returned blade.The heel of the returned blade did not break but the spatula twisted during test.Out of the three returned sample, only one was found with no detected problems.We further reviewed the complaint history of the similar nature complaint." 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 that " during the insertion of the blade in the throat the blade broke at the level of the green plastic connection.Additional information: patient consequence was that there was a delay in the procedure as they had to try other blades.The entire blade was removed with no part left in the patient.It is reported that the patient is deceased but not as a cause of the incident.2 blades broke.Associated complaints 9681900-2023-00030, 9681900-2023-00031 and 9681900-2023-00029.
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Search Alerts/Recalls
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