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Model Number STAPLE SEATING PUNCH |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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On (b)(6) 2024, it was reported by a sales representative via (b)(4) that when the rep twisted the top part to disengage the screw, the tip unevenly clamps down and doesn't close evenly with the driver discovered during a case, no adverse affect to the patient.
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Search Alerts/Recalls
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