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Model Number TPW32 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested and the following was obtained: what was the name of the procedure?- no procedure involved at time of issue.What was the procedure date? n/a.Have any of these events been previously reported to ethicon? not from my department.What is the lot number? copied our supply chain for this (mark) what was used to complete the procedure? n/a.Was there any adverse patient outcome? none- only delay in being able to cardiac pace patient.If yes, was there any medical or surgical intervention performed? what is the patient¿s current status? n/a.Device return status n/a.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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Event Description
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It was reported that a patient underwent an unknown procedure on an unknown date and temporary pacing wire was used.The wire fractured at the junction of the metal blunt needle and wire.Due to the issue, there was delay in being able to cardiac pace the patient, however, there were no adverse patient consequences.Additional information was requested.
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Search Alerts/Recalls
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